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+Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:             \r\n* Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)\r\n* Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml\r\n* Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL\r\n* Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure
+Baseline PSA nadir >= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration
+Post-prostatectomy patients with a detectable serum PSA (>= 0.1, but =< 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:\r\n* Gleason score 7-10 (International Society of Urological Pathology [ISUP] grade group 2 to 5)\r\n* ISUP grade group:\r\n** Grade group 1?=?Gleason score?=<?6, \r\n** Grade group 2?=?Gleason score 3?+?4?=?7,\r\n** Grade group 3?=?Gleason score 4?+?3?=?7, \r\n** Grade group 4?=?Gleason score 8, \r\n** Grade group 5?=?Gleason scores 9 and 10\r\n* >= T3a disease\r\n* Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of > 0.04 but < 0.2 ng/mL (PSA nadir)
+Previously untreated localized adenocarcinoma of the prostate with the following clinical findings:\r\n* Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side of the gland); (American Joint Committee on Cancer [AJCC], version 7) or cT1a-c or 2a or 2b, stage group IIA or IIB (AJCC, version 8); both versions 7 and 8 staging should be recorded\r\n* Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements\r\n* Stages T1a-T1b are eligible if patient underwent transurethral prostatic resection (TURP) previously Gleason score must be Gleason 7(3+4) with a PSA < 20 ng/mL, or Gleason 6(3+3) with a PSA > 10 ng/mL and < 20 ng/mL; (AJCC, version 7) or group grade 1 or 2, stage Group IIA or IIB (AJCC version 8)\r\n** If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment the baseline PSA value will be assumed to be double the initial value and the medication should be discontinued but does not need to have a washout period to participate, to remain eligible a PSA drawn while still on the medicine must be:\r\n*** < 10 ng/mL to remain eligible if Gleason 7(3+4) \r\n**** Stratification level 1 if PSA < 5 ng/mL and level 2 if less than 10 ng/mL\r\n*** > 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3) \r\n**** Stratification level 3\r\n* Percent of submitted positive core biopsies must be < 50% of all sextants\r\n** NOTE: all cores from a targeted lesion will be counted as an N of 1 core for calculating percent positive cores in total\r\n* The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including magnetic resonance imaging (MRI) or computed tomography (CT) scan
+Documented progressive metastatic (m)CRPC based on at least one of the following criteria:\r\n* PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL\r\n* Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions\r\n* Progression of bone disease (evaluable disease) or (new bone lesion[s]) by bone scan
+Recurrent prostate cancer following primary therapy as defined by:\r\n* Post-radical prostatectomy: Any PSA >= 0.4 ng/ml\r\n* Post-primary radiotherapy: PSA >= 2 ng/ml above a post-radiotherapy nadir\r\n* Post-primary androgen-deprivation therapy: A confirmed rise of PSA >= 2 ng/ml above a post-therapy nadir
+PSA at screening must be ?2 µg/L.
+Last PSA value should have increase of ? 25% of the first PSA value and an absolute increase of ?2 ng/mL over the first PSA value
+Prostate- specific antigen (PSA) Progression: An elevated PSA ?2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 < PSA2 < PSA3). If the 3rd PSA value is less than the 2nd PSA value, than an additional test for rising PSA is required to document progression. (For the purposes of the nomogram calculator, the last PSA value recorded prior to initiation of the intervention will be considered the baseline PSA)
+PSA ? 2 ng/ml
+Progressive disease during (or within 4 weeks of completion) with abiraterone, enzalutamide, and/or androgen receptor antagonist ARN-509 (ARN-509) based on any one of the following:\r\n* For patients with measurable disease, progression by the Response Evaluation Criteria in Solid Tumors (RECIST)\r\n* PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart; if the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA will be required to document progression for the purposes of eligibility\r\n* Radionuclide bone scan: at least two new foci consistent with metastatic lesions
+PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery
+Evidence of disease recurrence or progression as evidenced by a PSA > 0.20; this requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir or one PSA value above 0.20 ng/mL if the patient failed to achieve a post-prostatectomy nadir of < 0.2 ng/mL
+PSA > 4.0 ng/mL
+Confirmation of detectable PSA after radical prostatectomy, OR presence of extracapsular extension, seminal vesicle invasion or positive surgical margin if postoperative PSA is undetectable (adjuvant RT)
+Baseline (pre-treatment) serum troponin T (TnT) >= 0.03 ng/mL; Troponin T levels may be rechecked and therapy given if levels decrease to < 0.03 ng/mL
+PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
+Biochemical progression (rising PSA) after medical or surgical castration
+Rising PSA as defined above and either:
+Absolute PSA > 20 ng/mL AND/OR
+PSA doubling time < 8 months
+Evidence of rising PSA, on 2 separate occasions, at least one week apart; baseline PSA must be >= 0.2 ng/mL at the time of screening; radiographic evidence of disease is not allowed
+Patients must have sufficient PSA time points prior to enrollment (a minimum of 3 PSA levels within a six month period) to calculate a baseline PSA doubling time
+Patients who have PSA recurrence after local salvage therapy may participate in this study
+Very fast PSA doubling time of less than 4 weeks, if the absolute PSA is > 2 ng/mL or an absolute PSA value of greater than or equal to 20 ng/ml
+Documented progressive metastatic CRPC based on at least one of the following criteria: \r\n* PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL\r\n* Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions or the appearance of new lesions\r\n* Documented appearance of new lesions by bone scan
+Subject must not have had more than 24 months of hormonal therapy in combination with prostatectomy or radiation in the setting of localized disease and must not have shown any evidence of disease recurrence within 12 months after stopping hormonal therapy; disease recurrence after hormonal therapy is defined as PSA > 0.2 ng/dl after prostatectomy + hormonal therapy or PSA that is 2.0 ng/dl more than the PSA nadir after radiotherapy + hormonal therapy; previous hormonal therapy to the prostate must have stopped at least 12 months prior to enrollment
+Biochemically recurrent prostate cancer with PSA doubling time ? 9 months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past 12 months prior to randomization, with a minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to localized therapy will be excluded. PSA doubling time to be estimated using Memorial Sloan Kettering Cancer Center online calculator (https://www.mskcc.org/nomograms/prostate/psa-doubling-time)
+Screening PSA > 0.5 ng/mL
+Screening PSA must be >= 1.0 ng/mL
+Patients must be withdrawn from abiraterone for >= 2 weeks and have documented PSA increase after the 2 week withdrawal period
+Prostate specific antigen (PSA) < 20, within 6 months of study entry\r\n* Participants who are currently receiving dutasteride (or have received it within the last 90 days) or finasteride (or have received it within the last 30 days) must have a PSA of =< 10
+Clinical stage T1-2 N0 M0, Gleason score =< 7, PSA 20-100 ng/mL, or clinical stage any T N0 M0, Gleason score 8 -10, PSA =< 100 ng/mL, or clinical stage T3-4 N0 M0, any Gleason score, PSA =< 100 ng/mL, or clinical stage T1-2 N0 M0, Gleason score 4 + 3, PSA 10-20 ng/mL
+PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml
+PSA must be < 30 ng/mL at study entry
+Patient must have evidence of biochemical failure after primary therapy and subsequent progression; biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy\r\n* For radical prostatectomy the threshold for this study is PSA >= 0.2 ng/mL\r\n* For radiation therapy the threshold is a PSA rise of 2 ng/mL above the nadir PSA achieved post radiation with or without hormone therapy (2006 Radiation Therapy Oncology Group [RTOG]-American Society for Radiation Oncology [ASTRO] Consensus definition)\r\n* PSA progression requires a PSA rise above the threshold measured at any time point since the threshold was reached
+PSA doubling time between 3 and 9 months; PSA calculation requires at least two consecutive PSA rises (PSA2 and PSA3) above the threshold PSA (at least 3 PSA values); PSA2 and PSA3 must be obtained within 12 months of study entry; all baseline PSAs should be obtained at the same reference laboratory (lab); patient's PSA doubling time must be calculated
+Castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (=< 50 ng/dL), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (ADT), as demonstrated by two consecutive rises in prostate-specific androgen (PSA) OR new lesions on bone scan:\r\n* PSA progression will be defined as 2 rising PSA values compared to a reference value, measured at least 7 days apart and the second value is >= 2 ng/mL; it must be documented within 2 months of screening\r\n* Appearance of one or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response; increased uptake of pre-existing lesions on bone scan does not constitute progression; it must be documented within 4 months of screening
+Serum PSA >= 2.0 ng/mL
+PSA doubling time (PSADT) >= 3 months and =< 15 months:\r\n* Patients must have >= 3 PSA measurements over >= 3 months\r\n* The interval between PSA measurements must be >= 4 weeks
+For patients following radical prostatectomy: 2 absolute PSA values > 0.2 ng/ml
+Progressive disease by PSA or imaging in the setting of medical or surgical castration; disease progression for study entry is defined as one or more of the following three criteria:\r\n* PSA evidence for progressive prostate cancer which consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least 1 week apart; if the confirmatory PSA value is less than the screening value, then an additional PSA value greater than #2 will be required to document progression of >= 1 week\r\n** PSA values to be obtained >= 1 week apart\r\n* Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\r\n* Bone disease progression defined by two or more new lesions on bone scan
+History of progressive disease after androgen deprivation, defined by one OR both of the following:\r\n* Objective radiographic progression defined by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria\r\n* Prostate-specific antigen (PSA) evidence for progressive prostate cancer which consists of a PSA level of at least 2 ng/ml, which has risen on at least 2 successive occasions, at least 1 week apart; if the confirmatory PSA value is not greater than the screening PSA value, then an additional test for rising PSA will be required to document progression
+PSA >= 2 ng/mL
+Serum PSA =< 10.0 ng/ml
+PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
+Documented progressive metastatic castrate resistant prostate cancer (mCRPC) based on at least one of the following criteria:\r\n* PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL\r\n* Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions\r\n* Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan
+PSA values < 2 ng/ml within 90 days prior to enrollment. Obtained at least 6 weeks after surgery
+Progression must be evidenced and documented by any of the following parameters:\r\n* PSA progression defined by a minimum of two rising PSA levels with an interval of >= 1 week between each determination\r\n* Appearance of one or more new lesions consistent with prostate cancer on bone scan\r\n* New or growing lesions on computed tomography (CT) scan
+Radiological confirmation of metastatic disease, or \r\n* Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone: \r\n** Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer OR \r\n** Prostate specific antigen (PSA) progression defined by sequence of rising values separated by > 1 week (2 separate increasing values over a minimum of 1 ng/ml [prostate cancer working group 3 (PCWG3) PSA eligibility criteria]); if patients had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal; for patients on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal; the requirement for a 4-6 week withdrawal period following discontinuation of flutamide, nilutamide or bicalutamide only applies to patients who have been on these drugs for at least the prior 6 months; for all other patients they must stop bicalutamide, nilutamide or flutamide the day prior to enrollment
+Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone:\r\n* Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer\r\n* PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values over a minimum of 2ng/ml (Prostate Cancer Working Group 2 [PCWG2] PSA eligibility criteria); if patients had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal; for patients on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal; the requirement for a 4-6 week withdrawal period following discontinuation of flutamide, nilutamide or bicalutamide only applies to patients who have been on these drugs for at least the prior 6 months; for all other patients, they must stop bicalutamide, nilutamide or flutamide the day prior to enrollment
+Progressive disease by PSA or imaging after most recent prior therapy. PSA ?1 ng/mL, if a confirmed rise in PSA is the only indication of progression. Progression by PSA requires rising PSA over a previous reference value by at least 2 measurements obtained ? 1 week apart.
+Two rising PSA values separated by at least 1 week, one showing a rise of at least 0.5 ng/mL and one confirmatory value not showing a decline, while on abiraterone therapy.
+A minimum of 10 core biopsies must be obtained at baseline. A prostate biopsy within 6 months from screening is allowed for entry requirements. Patients must meet intermediate risk criteria from Gleason score, T stage, and prostate specific antigen (PSA) value by National Comprehensive Cancer Network (NCCN) criteria: cT2b-T2c or Gleason 7 (3+4 or 4+3) or PSA 10-20 ng/mL. In addition, the Gleason 3+4 or 4+3 must be present
+Indications for post-prostatectomy radiation exist:\r\n* Disease progression (detectable PSA on two measurements obtained at least one month apart) or\r\n* Indications for adjuvant radiation exist (if undetectable PSA): pathologic T3, T4, N+ disease or positive margins (within 1 year of prostatectomy)
+Patients must have histologically confirmed progressive, metastatic castration resistant prostate adenocarcinoma by meeting ALL the following:\r\n* Pathology of prostate gland or metastatic disease must confirm the diagnosis of prostate adenocarcinoma; mixed histology with other variants including but not limited to small cell or neuroendocrine differentiation must be discussed with the study principal investigator (PI) \r\n* Metastasis must be documented by radiographic evidence\r\n* Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/d (< 2.0 nM); if the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who has not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to cycle 1, day 1 and must be continued throughout the study\r\n* Progression must be evidenced and documented by any of the following parameters\r\n** Two consecutively rising PSA values, above the baseline, at a minimum of 1-week intervals; the minimal value to enter the study is 1.0 ng/ml or greater; the reference value (#1) is the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart; if the PSA at time point 3 (value #3A) is greater than that at point 2, then eligibility has been met; if the PSA is not greater than point 2 (value #3B), but value #4 is, the patient is eligible assuming that other criteria are met, if values 3A or #4 are 1 ng/mL or higher (Prostate Cancer Working Group 3)\r\n** Appearance of one or more new lesions on bone scan\r\n** Progressive disease by RECIST 1.1
+Progressive disease defined as one or more of the following three criteria (NOTE: Patients who received an antiandrogen must demonstrate disease progression following discontinuation of antiandrogen): \r\n* PSA progression defined by a minimum of two rising PSA levels with an interval of >= 1 weeks between each determination. The PSA value at the screening visit should be >= 2 ng/mL \r\n* Soft tissue disease progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) \r\n* Bone disease progression defined by two or more new lesions on bone scan
+High risk prostate cancer defined as extracapsular extension (cT3a) or seminal vesicle involvement (cT3b) or invasion of adjacent structures (cT4), serum PSA > 20 ng/mL or Gleason score of 8 to 10 and/or regional lymph node or
+Has a serum vitamin D level of ? 50 ng/mL
+Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone:\r\n* Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer OR\r\n* PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values over a minimum of 2ng/ml [Prostate Cancer Working Group 2 (PCWG2) PSA eligibility criteria); if patients had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal; for patients on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal
+Biochemical progression defined as follows:\r\n* For patients following definitive radiation therapy: a rise in PSA of >= 2 ng/mL above the nadir (per Radiation Therapy Oncology Group [RTOG]- American Society for Radiation Oncology [ASTRO] consensus criteria)\r\n* For patients following radical prostatectomy: rising PSA after surgical procedure (patients must have a PSA >= 0.8 ng/mL)
+Patients must have a rising PSA as confirmed by 3 values a minimum of 1 week apart over at least a 1 month period of time
+Patients must have a PSA doubling time of 5-15 months
+PSA =< 30 ng/mL
+Serum PSA ?10 ng/mL.
+PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery
+Evidence of disease recurrence or progression as evidenced by a PSA > 0.20 ng/ml; this requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir or one PSA value above 0.20 ng/mL if the patient failed to achieve a post-prostatectomy nadir of < 0.2 ng/mL
+PSA ? 4.0 ng/mL
+Patients must have documented evidence of progressive disease as defined by any of the following: \r\n* PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least >= 1.0 ng/mL.\r\n* New or increasing non-bone disease (RECIST).\r\n* Positive bone scan with 2 or more new lesions (Prostate Cancer Working Group 2 [PCWG2]).
+PSA >= 4 ng/ml
+PSA failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least 2 ng/dL above post-radiotherapy nadir)
+PSA >= 20 ng/dL
+Disease progression defined by one or more of the following three criteria:\r\n* PSA > 2.0 ng/mL and rising PSA by at least 2 consecutive measurements a minimum of 1-week apart\r\n* Soft tissue progression as defined by RECIST v1.1 criteria\r\n* Bone disease progression as defined by Prostate Cancer Working Group 3 (PCWG3)
+Documented progressive metastatic castration resistant prostate cancer (CRPC) based on at least one of the following criteria:\r\n* PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2.0 ng/mL; Note: if confirmed rise is the only indication of progression, a minimal starting value of 1.0 ng/mL is acceptable, unless pure small-cell carcinoma\r\n* Soft-tissue progression based on new lesions or growth of existing soft tissue metastases\r\n* Progression of bone disease (evaluable disease) or (new bone lesion[s]) by bone scan
+A minimum of 3 rising PSA values with an interval of at least 1 week between determinations. The screening central laboratory PSA value must be ? 2 ?g/L (2 ng/mL) if qualifying solely by PSA progression.
+Prostate-specific antigen (PSA) progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least >/= 1.0 ng/mL;
+Has a serum PSA concentration at the Screening visit of > 2.0 ng/mL (2.0 ?g/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 ?g/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 ?g/L) above the post interventional nadir;
+Creatinine =< 1.4 ng/mL for females; =< 1.5 ng/mL for males; patients with creatinine =< 2.0 ng/mL may still be eligible if in the opinion of the investigator, the benefits of treatment outweigh the risks
+Absolute PSA >=1 ng/ml; prior undetectable PSA post-prostatectomy is not required
+Have received at least 4 cycles of docetaxel or cabazitaxel, and less than ten, with two consecutive rising PSA values, checked at least 7 days apart
+Subjects must have progressive disease at study entry defined as 1 or more of the following 3 criteria that occurred while the subject was on androgen deprivation therapy:\r\n* PSA progression defined by a minimum of two rising PSA levels with an interval of >= 1 week between each determination; subjects who received an anti-androgen as part of their primary hormonal therapy must demonstrate progression after withdrawal; the PSA value at screening should be >= 2 ug/L (2 ng/mL)\r\n* Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\r\n* Bone disease progression defined by PCWG3 with two or more new lesions on bone scan\r\n* Note: for subjects enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan performed during prior therapy; if the comparison scan is not available, the baseline scan report must reference the previous scan to document progression
+PSA progression defined by a minimum of two rising PSA levels with an interval of >= 1 week between each determination; patients who received an anti-androgen must have progression documented by a minimum of two rising PSA levels with an interval of >= 1 week between each determination such that at least the second of these rises is > 4 weeks since last flutamide or > 6 weeks since last bicalutamide or nilutamide; the PSA value at the screening should be > 2 ug/L (2 ng/mL)
+Documented progressive mCRPC based on at least one of the following criteria:\r\n* PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2.0 ng/mL\r\n* Progression of bidimensionally measurable soft tissue or nodal metastasis assessed within 42 days prior to registration by a computed tomography (CT) scan or magnetic resonance imaging (MRI)\r\n* Progression of bone disease (evaluable disease) (new bone lesion[s]) by bone scan
+PSA > 2 ng/mL at baseline or prior to initiation of hormonal therapy
+Screening PSA must be >= 1.0 ng/mL
+Evidence of disease progression on ADT as evidenced by one of the following:\r\n* 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR\r\n* Computed tomography (CT) or magnetic resonance imaging (MRI) based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to Prostate Cancer Working Group 3 (PCWG3) criteria or Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies, OR\r\n* Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of >= 1 week between each PSA level
+Baseline serum ferritin level >= 300 ng/mL
+Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable):\r\n* Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug\r\n* Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans)\r\n* Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (2nd beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
+Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone\r\ni. Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer OR\r\nii. PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values over a minimum of 2 ng/ml [Prostate Cancer Working Group (PCWG)2 PSA eligibility criteria]); if patients had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal; for patients on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal
+PSA blood test within 60 days prior to registration
+Castration resistant disease defined as evidence of radiological and/or prostate specific antigen (PSA) progression despite castrate levels of testosterone (serum testosterone < 50 ng/dL [1.7 nmol/L]); for PSA progression, there must be at least 2 sequential rises at a minimum of 1-week intervals; the first PSA value must be >= 4 (Prostate Cancer Working Group 2 [PCWG2] criteria)
+Subjects with a rising PSA value > 2 ng/mL in at least 2 measurements, at least 1 week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required to document progression.
+Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable):\r\n* Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug\r\n* Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans)\r\n* Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (second [2nd] beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
+Serum ferritin < 50 ng/mL
+Favorable risk prostate cancer as defined by:\r\n* Very low-risk:\r\n** Clinical stage T1c disease\r\n** PSA density (PSAD) < 0.15 ng/mL\r\n** Gleason score 6\r\n** =< 2 core biopsies with =< 50% involvement of any biopsy core with cancer, or unilateral disease =< 2 core biopsies with any percentage involvement OR\r\n* Low risk:\r\n** Clinical stage =< T2a\r\n** PSA < 10 ng/mL\r\n** Gleason score 6 OR\r\n* Low-intermediate risk:\r\n** Clinical stage T1c\r\n** PSA < 10 ng/ml\r\n** Gleason 3+4 present in =< 50% of one core/site as detected by systematic biopsy or MRI/transrectal ultrasound (TRUS) fusion guided biopsy\r\n** Gleason 6 disease in all other cores (maximum of 2 cores with =< 50% involvement of any core, or if unilateral disease, any percentage involvement)
+Patients must have documented evidence of progressive disease as defined by any of the following: \r\n* Prostate-specific antigen (PSA) progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least >= 1.0 ng/mL; \r\n* New or increasing non-bone disease (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1); \r\n* Positive bone scan with 2 or more new lesions (Prostate Cancer Clinical Trials Working Group [PCWG]3)
+Evidence of rising PSA on ADT
+Men with a diagnosis of very low risk (< 5% risk of disease relapse after primary treatment, criteria; cT1c, Gleason =< 6, prostate-specific antigen (PSA) < 10 ng/mL, fewer than 3 positive biopsy cores =< 50% cancer in any core, PSA density < 0.15 ng/mL/g); low risk (10% risk of disease relapse after primary treatment, criteria; cT1-2a, Gleason =< 6, PSA < 10 ng/mL) prostate cancer
+Baseline serum vitamin D total 25-hydroxy level below 66 ng/ml
+Known castration?resistant disease, defined according to Prostate Cancer Working Group 2 (PCWG2) criteria as:\r\n* Castrate serum testosterone level: =< 50 ng/dL (=< 1.7 nmol/L)\r\n* Subjects who have failed initial hormonal therapy, either by orchiectomy or by using a gonadotropin-releasing hormone (GnRH) agonist in combination with an anti?androgen, must first progress through antiandrogen withdrawal prior to being eligible; the minimum timeframe to document failure of anti?androgen withdrawal will be four weeks\r\n* Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least one week apart; serum PSA at screening >= 2 ng/mL OR\r\n** Documented bone lesions by the appearance of two or more new lesions by bone scintigraphy OR\r\n** Bidimensionally?measureable soft tissue metastatic lesion assessed by computed tomography (CT) or magnetic resonance imaging (MRI)
+Castration resistant prostate cancer as defined by rising PSA when serum testosterone < 50 ng/ml (note: current testosterone results are not required if the potential subject has not missed any GnRH analogue/antagonist doses since their last result was received) AND one of the following:\r\n* PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart\r\n* Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors)\r\n* Progression of metastatic bone disease on bone scan with > 2 new lesions
+Prostate specific antigen (PSA) =< 80 ng/ml, obtained within 3 months
+Patient has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization
+Castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and at least one of the following:\r\n* PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart\r\n* Evaluable disease progression by modified RECIST 1.1\r\n* Progression of metastatic bone disease on bone scan with > 2 new lesions
+Serum PSA <20 ng/ml
+PSA >= 0.1 after radical prostatectomy (value w/in 3 months of registration) AND at least 1 unfavorable risk factor listed below\r\n* Gleason 8-10\r\n* PSA > 0.5\r\n* Pathologically positive lymph nodes\r\n* pT3 or pT4\r\n* PSA doubling time (DT) < 10 months\r\n* Negative margins\r\n* Persistent PSA after radical prostatectomy (RP) (PSA never dropped below 0.1 after RP)\r\n* Local/regional recurrence on imaging\r\n* Decipher “high risk” (a Medicare-reimbursed test for risk of metastases after prostatectomy)
+PSA > 10 ng/mL in screening
+Most recent prostate specific antigen (PSA) within 60 days of enrollment
+Maximum PSA =< 20 ng/ml (not within 20 days after biopsy)
+Have metastatic castration-resistant prostate cancer, are chemo-naïve for mCRPC (however, six cycles of docetaxel are allowed in hormone-sensitive disease), and have progressed on abiraterone treatment (patients may have had prior therapy including sipuleucel-T, radium-223, abiraterone, ketoconazole, and/or Tak-700); progression on abiraterone is defined as\r\n* Radiologic progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group (PCWG)2 criteria, or \r\n* PSA progression on abiraterone:\r\n** For responders to abiraterone: 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir, confirmed by a second value obtained 2 or more weeks later\r\n** For non-responders to abiraterone: 25% increase above baseline with an increase in absolute value of 2 ng/mL or more after 12 weeks of treatment
+PSA > 100 ng/mL
+One of the following pathologic classifications\r\n* T3N0 disease with or without a positive surgical margin or\r\n* T2N0 disease with or without a positive surgical margin\r\n** Those with T2N0 disease and a negative margin must have a detectable prostate-specific antigen (PSA) following radical prostatectomy or\r\n** Must have had an undetectable PSA after prostatectomy and has since had a rise in post-operative PSA to 0.2 ng/mL or greater
+PSA < 150 ng/mL
+PSA >= 150 ng/mL
+Patients must have histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable; patients must have prostate cancer deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation and anti-androgen withdrawal when applicable):\r\n* Progression of unidimensionally measurable disease assessed within 28 days prior to initial administration of drug\r\n* Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g, bone scans)\r\n* NOTE: rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (2nd beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA is required to be taken and be greater than the second measure; measurable disease is not required
+For patients with metastatic prostate cancer, PSA >= 2 ng/mL, except for patients who have recently started androgen deprivation therapy with PSA < 2 ng/mL
+Prostate specific antigen (PSA) =< 10 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
+Patients with rising PSA on two successive measurements at least 2 weeks apart
+Patients must be candidates for long-term androgen deprivation in combination with EBRT for the treatment of high-risk or locally-advanced prostate cancer by the following criteria:\r\n* High risk disease: T3a or Gleason 8-10 or serum PSA > 20 ng/mL\r\n* Gleason 7 also allowed if > 50% of cores positive for cancer or PSA velocity > 2 ng/mL/year in preceding 12 months\r\n* Locally advanced (very high risk) disease: T3b-T4
+Serum PSA > 160 ng/dL
+Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations:\r\n* Gleason score 7-10 + T1c-T2b (palpation) + prostate specific antigen (PSA) < 75 ng/ml (includes intermediate and high risk patients)\r\n* Gleason score 6 + T2c-T4 (palpation) or > 50% (positive) biopsies + PSA < 75 ng/ml\r\n* Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/ml
+Baseline vitamin D level greater than 50 ng/mL
+Clinical stage T1-2b (American Joint Committee on Cancer [AJCC] 7th edition) and PSA < 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
+Prostate specific antigen (PSA) >= 0.2 ng/ml that is confirmed with a second PSA measurement
+PSA >= 2.0 ng/mL
+Evidence of castration resistant disease in the setting of ongoing ADT (medical or surgical) as evidenced by one of the following:\r\n* Absolute rise in PSA of 2.0 ng/mL or an increase > 25% from the nadir, minimum 2 consecutive rising PSA levels with an interval of >= 1 week between each PSA level, OR\r\n* Computed tomography (CT) or magnetic resonance imaging (MRI) based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to RECIST 1.1 criteria, OR\r\n* At least 1 new bone scan lesion as compared to the most immediate prior radiologic studies
+Prostate cancer categorized (as determined by central pathology review) as low risk is defined as T1c-T2a, PSA<10, N0, M0 (or presumed N0, M0 if CT/bone scan not done due to low risk of metastases), GS ? 6, ECOG status ?2 and estimated life expectancy >5 years OR intermediate risk is defined as T2b-T2c, PSA<20, N0, M0 (or presumed N0, M0 if CT/bone scan not done), GS ?7 (3+4 pattern only), ECOG status ? 2 and estimated life expectancy > 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ?6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ?50% cancer in any core, PSA density <0.15 ng/mL/g) is not included.
+Very low risk category (T1c, GS ?6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ?50% cancer in any core, PSA density <0.15 ng/mL/g)
+Intermediate or high risk for recurrence according to the following criteria:\r\n* Two or more of the following intermediate risk features for recurrence\r\n** Gleason score = 7\r\n** Prostate-specific antigen (PSA) 10-20 ng/ml\r\n** Clinical stage T2b-T2c\r\n** Percent positive biopsy cores >= 50% OR\r\n* One or more of the following high risk features for recurrence\r\n** Gleason score 8-10\r\n** PSA > 20 ng/ml\r\n** Clinical stage T3a-T4
+Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level < 15 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 50% of the total number of biopsy cores are involved by grade 3+4)
+PSA values < 20 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy
+PSA of greater than 10ng/ml
+Prostate specific antigen (PSA) =< 20 ng/dL
+Patients belonging in one of the following risk groups:\r\n* Low: clinical stage (CS( T1b-T2a and Gleason 2-6 and PSA =< 10, or\r\n* Intermediate: CS T2b and Gleason 2-6 and PSA =< 10, or CS T1b-T2b, and Gleason 2-6 and PSA =< 20 ng/dL, or Gleason 7 and PSA =< 10 ng/dL
+Most recent PSA value more than 18 months ago
+Prostate specific antigen (PSA) of less than 10 ng/ml
+PSA > 10 ng/ml
+A minimum of three PSA values, each at least 4 weeks apart, to calculate PSA-doubling time (DT); the last PSA level prior to enrollment must be at least 1.0 ng/mL and be rising over the prior value
+Key Eligibility Criteria:\n\n          -  Patients must have documented histological or cytological evidence of adenocarcinoma\n             of the prostate.\n\n          -  Must have progressive, metastatic castration-resistant prostate cancer (mCRPC). There\n             must be radiographic evidence of disease after primary treatment with surgery or\n             radiotherapy that has continued to progress radiographically or biochemically (rising\n             PSA levels on successive measurements) despite adequate androgen-deprivation therapy,\n             which is defined as having undergone bilateral surgical castration or continued\n             treatment on GnRH agonists or antagonists.\n\n          -  All patients in this trial must have been treated with enzalutamide.\n\n          -  Patients in Cohort 1 will not be allowed to have received prior chemotherapy; patients\n             in Cohort 2 must have received one (and not more) prior course of chemotherapy for\n             mCRPC.\n\n          -  Progression must be evidenced and documented by any of the following parameters:\n\n               -  PSA progression defined by a minimum of two rising PSA levels with an interval of\n                  ? 1 week between each determination\n\n               -  Appearance of one or more new lesions on bone scan\n\n               -  Progressive measurable disease by RECIST 1.1
+CEA plasma levels > 5 ng/mL.
+Inclusion Criteria: All of the following criteria are mandatory for inclusion:\n\n          -  Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores\n             taken within 18 months of randomisation.\n\n          -  Gleason score ? 3+4\n\n          -  Men aged ?18\n\n          -  Clinical and MRI stage T1c -T2c, N0-X, M0-X (TNM 6th Edition [72], See Appendix 1)\n\n          -  PSA ? 20 ng/ml\n\n          -  Pre-enrollment PSA must be completed within 60 days of randomisation\n\n          -  Patients belonging in one of the following risk groups according to the National\n             Comprehensive Cancer Network (www.nccn.org):\n\n               -  Low risk: Clinical stage T1-T2a and Gleason ? 6 and PSA < 10 ng/ml, or\n\n               -  Intermediate risk includes any one of the following:\n\n               -  Clinical stage T2b orT2c\n\n               -  PSA 10-20 ng/ml or\n\n               -  Gleason 3+4\n\n          -  WHO performance status 0 - 2\n\n          -  Prostate volume ? 90 cc measured within 6 months of randomisation (height*width*length\n             *?/6)\n\n          -  Ability of the research subject to understand and the willingness to sign a written\n             informed consent document\n\n        Exclusion criteria: One of the following criteria is sufficient for exclusion:\n\n          -  Clinical stage T3 or greater\n\n          -  Gleason score ? 4 + 3\n\n          -  High risk disease defined by National Comprehensive Cancer Network (www.nccn.org)\n\n          -  Previous malignancy within the last 2 years (except basal cell carcinoma or squamous\n             cell carcinoma of the skin), or if previous malignancy is expected to significantly\n             compromise 5 year survival\n\n          -  Prior pelvic radiotherapy\n\n          -  Prior androgen deprivation therapy (including LHRH agonists and antagonists and\n             anti-androgens)\n\n          -  Any prior active treatment for prostate cancer. Patients previously on active\n             surveillance are eligible if they continue to meet all other eligibility criteria.\n\n          -  Life expectancy <5 years\n\n          -  Bilateral hip prostheses or any other implants/hardware that would introduce\n             substantial CT artifacts\n\n          -  Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel\n             disease, significant urinary symptoms\n\n          -  Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery\n             unsafe in the opinion of the clinician (see section 11, Treatment).\n\n          -  Participation in another concurrent treatment protocol for prostate cancer
+PSA must be at least 1 ng/ml and rising on two successive measurements at least two weeks apart
+Castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
+CEA plasma levels > 5 ng/mL
+Progressive, castration-resistant prostate cancer demonstrated during continuous antiandrogen therapy (ADT), defined as 3 PSA rises at least 1 week apart, with the last PSA > 2 ng/mL
+Patients who received a first generation anti-androgen (e.g., bicalutamide, flutamide, nilutamide) as most recent treatment must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after washout
+Castration resistance will be defined as the development of disease progression, defined as one of the following:\r\n* Rising PSA x 2 values >= 2 weeks apart; minimum absolute PSA value 2 ng/mL\r\n* Radiographic progression, with at least 1 new site of metastasis\r\n* Symptomatic progression (ex: increase in pain despite stable imaging) AND despite ongoing luteinizing hormone-releasing hormone (LHRH) therapy OR testosterone level < 50
+Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable):\r\n* Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug\r\n* Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans)\r\n* Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (2nd beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
+Documented prostate cancer progression as assessed by the investigator with one of the following: PSA progression defined by a minimum of 3 rising PSA levels with an interval of >=1 week between each determination. The PSA value at screening must be >=5 microgram (µg)/L (5 ng/mL) if PSA is the only indication of progression; subjects on systemic glucocorticoids for control of symptoms must have documented PSA progression by PCWG3 while on systemic glucocorticoids prior to commencing Cycle 1 Day 1 treatment.
+Prostate cancer with a current PSA level < 0.1 ng/mL.
+Must have a vitamin D level >= 30 ng/mL after repletion
+Intermediate risk or high risk prostate cancer patients who are candidates for radiation therapy:\r\n* Gleason >= 7 or\r\n* Clinical or pathological > T2b disease or\r\n* Prostate-specific antigen (PSA) >= 10 ng/mL
+Serum ferritin < 50 ng/mL.
+No distant metastases on bone scan (only necessary if prostate specific antigen [PSA] >= 10 ng/ml and/or Gleason score >= 7)
+PSA is mandatory (< 60 days prior to registration)
+Normal serum CEA levels (< 3 ng/ml) at the time of registration
+Patients must have rising PSA on two successive measurements, at least 2 weeks apart
+Serum prostate specific antigen (PSA) level < 20 ng/ml
+Serum PSA level > 20 ng/ml
+Prostate-specific antigen (PSA) < 10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
+Castration-resistant based on a current or historical evidence of disease progression despite surgical or medical castration as demonstrated by one or more of the following:\r\n* Prostate-specific antigen (PSA) progression (defined as two consecutive PSA measurements at least 14 days apart >= 2.0 ng/ml and >= 50% above the minimum PSA during castration therapy or above pre-treatment value if no response)\r\n* Progression of measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) (>= 20% increase in the sum of the diameters of all target lesions or the development of any new lesions)\r\n* Progression of non-measureable disease based on imaging studies
+Serum PSA >= 2.0 ng/ml at study enrollment
+Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with the patients falling into either the “adjuvant high risk group” or the “salvage high risk group” as indicated below; in those cases where patients undergo a prostatectomy without any sampling of the pelvic lymph nodes, patients will be also considered eligible if they are found to have a negative pelvic computed tomography (CT) or magnetic resonance imaging (MRI) scan which shows no evidence of lymphatic nodal metastases after the prostatectomy\r\n* “Adjuvant High Risk Group” (undetectable, persistent or decreasing PSA levels before starting therapy) who have NO evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence) who MUST be able to start RT treatments within 6 months of radical prostatectomy with at least one of the 3 disease features:\r\n** Pathologic T2N0 disease and Gleason score >= 8, or\r\n** Pathologic T3aN0 disease with extracapsular extension and Gleason score >= 8, or\r\n** Pathologic T3bN0 disease with any Gleason score\r\n* “Salvage High Risk Group” are those patients with PSA biochemical failure defined by at least 1 detectable PSA level >= 0.2 ng/ml or at least 2 consecutive increases over baseline PSA levels at least one month apart, who have NO other evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence), and WITH AT LEAST ONE of the high risk disease features as defined below:\r\n** Pathologic T3bN0 disease with any Gleason score, or\r\n** Pathologic T2-3aN0 disease with Gleason score >= 8, or\r\n** Pathologic T2-3aN0 disease with PSA doubling time =< 10 months, or\r\n** Pathologic T2-3aN0 disease with pre-radiation therapy PSA level >= 1.0 ng/ml
+Patients must have a PSA >= 2 ng/mL obtained within 90 days prior to registration
+Serum PSA <10 ng/mL undergoing active surveillance may be enrolled with agreement of the sponsor.
+Subjects must have castrate levels of testosterone (?50 ng/dl [1.7 nmol/L]) and have progressive disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values ?1 week between each assessment. The PSA value at the Screening visit must be ?2ng/mL with or without:
+Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ?1 week between each assessment where the PSA value at screening should be ?2 ng/mL; radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression
+PSA doubling time ? 9 months;
+Screening PSA by the central laboratory ? 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
+PSA ? 15 ng/ml
+Patient must fit D’Amico intermediate-risk criteria by clinical stage (T2b-T2c), prostate-specific antigen (PSA) (10-20 ng/mL), and/or Gleason score (Gleason 7)
+PSA > 20 ng/ml
+Prostate-specific antigen doubling time of ? 10 months and PSA > 2ng/ml.
+PSA and the screening PSA assessed by the central laboratory (central PSA) should be ? 2 µg/L (2 ng/mL:
+PSA doubling time ? 10 months;
+Adenocarcinoma of the prostate proven by biopsy within 180 days of study registration with one of the following high risk criteria:\r\n* Gleason score 7 with PSA =< 20 ng/ml and clinical T1-2, or\r\n* Gleason score 8-10, PSA =< 20 ng/ml and clinical T1-2, or\r\n* PSA 10.1-40 ng/ml with Gleason score (GS) < 7 and clinical T1-2, or\r\n* Clinical T3 with Gleason score < 7 and PSA =< 10 ng/ml
+Specific eligibility criteria for Part 2 CRPC expansion cohort: Prostate-Specific Antigen (PSA) levels >=2.0 ng/mL. Note: If PSA level has been obtained within 14 days of Screening, this test does not need to be repeated and the result previously obtained may be used for the Screening value.
+PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.
+PSA progression defined as 25% increase over a baseline value of > 2 ng/ml with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval. Baseline is defined as the PSA nadir level since commencing most recent prior therapy
+A post-radical prostatectomy study entry PSA >= 45 days after prostatectomy and within 30 days prior to step 1, < 2.0 ng/mL
+A post-prostatectomy PSA nadir >= 0.2 ng/mL AND Gleason >= 7
+pT2 with a negative surgical margin and PSA < 0.1 ng/mL
+Serum prostate-specific antigen (PSA) ? 15ng/mL.
+PSA ? 20 ng/mL;
+PSA > 20 ng/mL
+Patients must have evidence of response to androgen deprivation as defined by a documented decline in serum PSA values from pre-androgen deprivation treatment baseline and without evidence of PSA progression while on androgen deprivation (defined by Prostate Cancer Working Group 2 [PCWG2] criteria as a 25% increase in serum PSA and an absolute increase of 2 ng/mL over nadir)
+Patients previously treated with neoadjuvant and/or adjuvant androgen deprivation (e.g. with radiation therapy) prior to the 6-month eligibility period are allowed, assuming they did not meet criteria for progression (defined by PCWG2 criteria as a 25% increase in serum PSA and an absolute increase of 2 ng/mL over nadir) while on treatment
+PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval with a minimum PSA of 2 ng/ml.
+Patients with a prostate serum antigen (PSA), equal to, or more than, 5 ng/mL.
+Increasing PSA level: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2. Inclusion criterion only for patients entering phase Ib expansion cohort:
+Patients must be receiving continuous enzalutamide treatment and show a rise in PSA level: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2.
+Prostate adenocarcinoma without distant metastatic disease with either Gleason score >= 7, PSA >= 10 ng/ml, or T2b or greater disease
+Prostate cancer with a current PSA level < 0.1 ng/mL.
+Adenocarcinoma of the prostate with intermediate risk disease T2b-T2c or Gleason score 7 or prostate specific antigen (PSA) 10-20 ng/ml, without metastatic disease
+PSA blood test within 60 days prior to registration
+Patient with PSA less than or equal to 10 ng/mL
+A diagnosis of progressive castrate metastatic prostate cancer defined as one or more of the following three criteria: \r\n* Soft tissue progression defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 \r\n* Bone disease progression defined by Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan \r\n* Post-hormonal therapy rising PSA values from a hormone therapy nadir on >= 3 successive determinations at least two weeks apart, where the increase above the nadir is the greater of >= 2.0 ng/mL or a >= 10% change; (subjects with a rise in PSA but no evidence of metastases at any time by imaging studies will NOT be eligible)
+PSA < 10 ng/mL =< 30 days prior to registration
+Prostatic specific antigen doubling time (PSADT) < 15 months; PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA > 0.2); to calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used
+PSA >= 0.5 but =< 50
+Biochemical progression after definitive radiation or surgery defined as follows:\r\n* For patients following definitive radiation therapy: a rise in PSA of >= 2 ng/mL above the nadir (per Radiation Therapy Oncology Group [RTOG]-American Society for Radiation Oncology [ASTRO] consensus criteria)\r\n* For patients following radical prostatectomy: rising PSA after surgical procedure; (patients must have a PSA >= 0.8 ng/ml)
+Patients must have a PSA doubling time of 5-15 months
+Patients must have a rising PSA as confirmed by 3 values done at least 1 week apart and over no less than 1 month
+PSA =< 30 ng/mL
+Patients with prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy), but with undetectable PSA (<0.2 ng/mL).
+Patients must have PSA progression after local treatment:\r\n* PSA values for patients after surgery (or surgery and salvage/adjuvant radiation) must be greater than 0.2 ng/mL, determined by two measurements, at least 1 month apart and at least 6 months after prostatectomy OR\r\n* PSA values for patients after radiation must be greater than or equal to 2.0 ng/ml greater than the nadir achieved after radiation, determined by two measurements at 1 month apart and at least 6 months after the radiation treatment is completed; (patients who received adjuvant or salvage radiation after prostatectomy must have PSA of greater than or equal to 0.2)\r\n* The first two PSA values, along with a third (study baseline) value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value)\r\n* PSA doubling time using the mkscc.org PSA doubling time calculator must be greater than 4 months
+Progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (PSA) values (PSA1 < PSA2 < PSA3);
+The screening PSA (PSA3) must be ? 2 ?g/L (? 2 ng/mL).
+Patients must have a minimum serum PSA level of >2 ng/ml that is rising based on the Prostate Cancer Working Group 2 criteria.
+The serum PSA should be less than or equal to 15 ng/ml; study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of androgen deprivation therapy (ADT); (3) within 30 days after discontinuation of finasteride; or (4) within 90 days after discontinuation of dutasteride
+Have a PSA or radiographic progression on enzalutamide; PSA progression is defined as two consecutive increases in PSA with the second level obtained at least 3 weeks after the first, and the second level of at least 0.5 ng/mL; soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or >= 2 new lesions on bone scan
+Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)
+Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period
+Prostate-specific antigen (PSA) < 20 ng/dl
+Evidence of disease progression on or after the most recent systemic treatment disease defined by the following criteria:\r\n* PSA: increasing PSA levels as defined by the Prostate Cancer Clinical Trials Working Group (PCWG2), determined by 2 consecutive measurements (compared to a baseline or nadir value); if the third measurement is below the second, then a fourth measurement must be greater than the second; the confirming third or fourth measurement must be >= 2 ng/mL; PSA progression must have occurred within 15 months of registration with at least 7 days between each PSA measurement; additionally the PSA progression as described above should have occurred during or after the most recent systemic treatment for prostate cancer\r\n* Measurable disease: >= 20% increase in the sum of the short axis diameter of all measurable lymph nodes or the development of any new measurable lymphadenopathy by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and PCWG2 criteria\r\n* Non-measurable disease:\r\n** Lymph node disease: appearance of 1 or more new lymphadenopathy, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response\r\n** Bone disease: appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response; increased uptake of pre-existing lesions on bone scan does not constitute progression
+Histologically confirmed prostate cancer with progressive metastatic disease based on any of the following: i) a rise in PSA, ii) transaxial imaging, or iii) radionuclide bone scan\r\n* PSA - a minimum of 3 consecutive rising levels, with an interval of >= 1 week between each determination; the last determination must have a minimal value of >= 2 ng/mL and be determined within two weeks prior to enrollment\r\n* Measurable disease - patients showing new or progressive soft tissue masses on computed tomography (CT) or magnetic resonance imaging (MRI) scans as defined by the Prostate Cancer Working Group 2 (PCWG2) criteria\r\n* Radionuclide bone scan - at least two new metastatic lesions
+Patients must have a minimum PSA >= 5 ng/mL within 60 days of registration or prior to the initiation of androgen deprivation for patients who have started androgen deprivation therapy
+Rising serum PSA levels documented by 3 values over the last 6 months prior to study enrollment. Each value must be greater than 2 weeks from the previous value.
+Progressive disease (PSA, radiologic, symptomatic) following abiraterone acetate and/or enzalutamide (prior chemotherapy and sipuleucel-T is allowed); PSA progression is defined as baseline increase followed by any PSA increase >= 1 week apart
+An elevated PSA level of > 2 ng/mL for patients progressing by PSA criteria is required (last confirmatory sample must be > 2 ng/mL)
+Serum PSA ?2 ng/mL (?g/L)
+Participants must have histologically confirmed malignancy and are candidates for external beam radiation therapy; patients eligible for this study must have intermediate risk disease defined as PSA values between 10-20 ng/ml and/or T2b-c and/or Gleason grade 7; if all three are present, less than 50% of the core biopsies can be positive
+Participants must have progressive disease as defined by one or more of the following:\r\n* Castrate resistant disease as defined by Prostate Cancer Working Group (PCWG)2; participants must have a rise in PSA on two successive determinations at least one week apart and PSA levels >= 2 ng/ml (only the screening PSA needs to be >= 2 ng/ml) and testosterone levels < 50 ng/dL\r\n* Soft tissue progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\r\n* Bone disease progression defined by PCWG2 with two or more new lesions on bone scan
+Serum PSA (Prostate specific antigen) progression defined as 2 subsequent increases in PSA over a previous reference value (a minimum of 2 ng/mL [?g/L]) OR
+COHORT B: Histologically confirmed prostate cancer with progressive disease, defined as:\r\n* Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart); the 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential\r\n* PSA doubling time of =< 12 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram
+Prostate-Specific Antigen (PSA) progression defined by a minimum of 2 rising PSA levels with an interval of at least 1 week between each draw;
+Serum PSA > 2.0 ng/mL; prostate cancer progression documented by PSA according to Prostate Cancer Working Group 2 (PCWG2) or radiographic progression according to modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria
+Patients must have evidence of biochemical (PSA) relapse after prostatectomy, defined by one rise in PSA above a baseline detectable value (>= 0.05 ng/mL) using measurements taken at least 4 weeks apart from each other (all PSA values must be within 12 months of study entry)
+Patients must have an absolute PSA level between > 0.05 and < 0.7 ng/mL at the time of study entry
+Patients must have progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy; for patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan; if the comparison scan is not available, the baseline scan report must reference the previous scan to document progression\r\n* PSA progression defined by a minimum of two rising PSA levels with an interval of >= 1 week between each determination; patients who received an anti-androgen must have progression documented by a minimum of two rising PSA levels with an interval of >=1 week between each determination such that at least the second of these rises is >= 4 weeks since last flutamide, bicalutamide or nilutamide; the PSA value at the screening should be >= 2 ug/L (2 ng/mL)\r\n* Soft tissue disease progression defined by at least 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study)\r\n* Bone disease progression defined by PCWG2 with two or more new lesions on bone scan
+Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises, at least 1 week apart, with the last PSA greater than (>) 2 nanogram per milliliter (ng/mL)
+Patients who received a first generation anti-androgen (for example, bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND must show continuing disease (PSA) progression (an increase in PSA) after washout
+Participants must have progressive disease as defined by either:\r\n* Castrate resistant disease as defined by Prostate Cancer Working Group (PCWG); participants must have a rise in PSA on two successive determinations at least one week apart and PSA levels >= 2 ng/ml (only the screening PSA needs to be >= 2 ng/ml) and testosterone levels < 50 ng/dL, OR\r\n* Soft tissue progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, OR\r\n* Bone disease progression defined by PCWG2 with two or more new lesions on bone scan
+PSA >= 2.0 ng/mL
+Evidence of disease progression on ADT as evidenced by one of the following:\r\n* Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA levels with an interval of >= 1 week between each PSA level, OR\r\n* 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR\r\n* Computed tomography (CT) or magnetic resonance imaging (MRI) based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to modified Prostate Cancer Working Group 2 (PCWG2) criteria or modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies
+Patients must have undergone a radical prostatectomy (any surgical technique is permitted) within 3 months from study entry and have high-risk disease define by any of the following:\r\n* Pathological stage T3a, T3b, T4 (any grade or initial prostate-specific antigen [iPSA])\r\n* Gleason sum >= 8 (any stage or iPSA)\r\n* Initial pre-operative PSA >= 20 ng/mL (any Gleason score [GS] or pT stage)\r\n* Any stage/PSA/Gleason patients with a 35% or greater chance of biochemical failure at 5 years based on Kattan's nomogram\r\n* Patients with lymph node (LN) positive disease, regardless of iPSA, pT stage or GS provided their post-operative PSA 6-8 weeks after surgery is =< 0.4 ng/mL (lymph node dissection is desired but not mandated)
+Baseline post-radical prostatectomy (RP) PSA =< 0.4
+Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry
+Patient must have a histological diagnosis of adenocarcinoma of the prostate and 2 rising pre-study PSA values >= 1 ng/ml at least 1 week apart within 28 days prior to enrollment
+Biochemical progression defined as follows:\r\n* For patients following definitive radiation therapy: a rise in PSA of >= 2 ng/mL above the nadir (per Radiation Therapy Oncology Group [RTOG]-American Society for Radiation Oncology [ASTRO] consensus criteria)\r\n* For patients following radical prostatectomy: rising PSA after surgical procedure (patients must have a PSA >= 2 ng/ml)
+Patients must have a PSA doubling time of 12 months or less
+Patients must have a rising PSA as confirmed by 3 values done at least 1 week apart and over no less than 1 month
+PSA =< 20 ng/mL
+Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone:\r\n* Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer OR\r\n* PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values over a minimum of 2 ng/ml [Prostate Cancer Clinical Trials Working Group (PCWG2) PSA eligibility criteria]); if patient has been on flutamide, PSA progression is documented 4 weeks or more after withdrawal; for patients on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal; the requirement for a 4-6 week withdrawal period following discontinuation of flutamide, nilutamide or bicalutamide only applies to patients who have been on these drugs for at least the prior 6 months; for all other patients they must stop bicalutamide, nilutamide or flutamide the day prior to enrollment
+All patients must meet one or more of the following disease features: clinical stage >= T3; primary Gleason score of 4 OR Gleason score of 8, 9 or 10; serum PSA >= 20 ng/mL; prostate magnetic resonance imaging (MRI) findings consistent with T3 disease; any clinical stage and PSA > 10 and Gleason score 7; a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of < 60%
+Patients must have a PSA >= 2 ng/mL at the time of diagnosis of prostate cancer or later
+PSA > 2 ng/mL
+Evidence of disease progression on ADT. Patients must have two serial rises in PSA from nadir, with at least 1 week between PSA measurements, with a minimum PSA of 2 ng/mL, OR patients must have radiographic evidence of progression. Nadir is defined as the lowest PSA value after beginning the most recent therapy for metastatic CRPC.
+PSA doubling time less than or equal to 12 months
+Minimum PSA 1.0 ng/mL if prior radical prostatectomy +/- adjuvant or salvage radiation; nadir + 2.0 ng/mL if prior RT without prior radical prostatectomy
+Prostate cancer recurrence after definitive local therapy (radical prostatectomy and/or radiation therapy) as evidenced by rising serum PSA, without evidence of metastases by bone scan or CT scan. a) After radiation: A rising PSA taken to indicate recurrent prostate cancer in patients with previous definitive external beam radiotherapy will be defined as PSA of 1.0, b) After Radical Prostatectomy: A rising PSA taken to indicate recurrent prostate cancer in patients with previous radical prostatectomy will be defined by the criteria of the American Urological Association as any PSA measurement of 0.2, with a subsequent measurement >0.2 ng/mL
+Histologically confirmed prostate cancer (per standards at institution of participant registration) currently with progressive disease, defined as:\r\n* Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart); the 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential; AND\r\n* Prostate-specific antigen doubling time (PSADT) =< 9 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram
+Androgen dependent disease measured by declining prostate-specific antigen (PSA) and do not display signs of progression demonstrated by a rising PSA
+Must have >= 3 serum PSA values obtained over at least a 12 week period of time prior to registration, including the day of screening, to calculate a PSA doubling time; Note: PSA’s are not required to be obtained at the same laboratory; use all PSA values that have been done in last 6 months to calculate PSA doubling time
+Must have metastatic, progressive, castrate resistant prostate cancer (CRPC); there must be radiographic evidence of disease after primary treatment with surgery or radiotherapy that has continued to progress radiographically or biochemically (rising prostate specific antigen [PSA] levels on successive measurements) despite adequate androgen-deprivation therapy, which is defined as having undergone bilateral surgical castration or continued treatment on gonadotropin-releasing hormone (GnRH) agonists or antagonists\r\n* Progression must be evidenced and documented by any of the following parameters:\r\n** Two consecutively rising PSA values, above the baseline, at a minimum of 1-week intervals\r\n** Appearance of one or more new lesions on bone scan\r\n** Progressive measurable disease by RECIST 1.1\r\n* The use of androgen receptor inhibitors is not required prior to study entry; for those patients receiving an anti-androgen agent (flutamide, bicalutamide, or nilutamide), for at least 6 consecutive months immediately prior to study entry, and are entering the trial due to a rise in PSA, they must demonstrate a continued rise in PSA within 4 weeks after stopping flutamide and within 6 weeks after stopping bicalutamide or nilutamide; flutamide, nilutamide and bicalutamide disease progression requirements only apply to patients who have been on these drugs for at least the prior 6 months
+Prostate specific antigen (PSA) > 1 ng/ml, unless anaplastic features are present
+Have progressive metastatic castration-resistant prostate cancer, on androgen-deprivation therapy, based on at least one of the following criteria:\r\n* PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1-week interval with a minimum PSA of 2 ng/mL\r\n* Progression of bidimensionally measurable soft tissue (nodal metastasis) assessed within one month prior to registration by a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen and pelvis\r\n* Progression of bone disease (evaluable disease) (new bone lesion[s]) by bone scan
+Patient must have biochemical evidence of prostate-specific antigen (PSA) including one of the following:\r\n* Biochemical recurrence (defined as nadir + 2 rises measured at least 2 weeks apart)\r\n* PSA doubling time of less than or equal to 6 months OR\r\n* Persistently elevated PSA (PSA post prostatectomy of 0.2 ng/mL if standard assay or greater than 0.05 if ultrasensitive PSA assay)
+Histologically or cytologically confirmed prostate cancer with progressive disease defined as either:\r\n* 2 or more new lesions on bone scan or\r\n* Progressive disease on computed tomography (CT)/magnetic resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria or\r\n* Rising PSA: PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart
+Inclusion Criteria: (Dose-Escalation Phase)\n\n          1. For the dose-escalation phase, patients must have cytologically or histologically\n             proven advanced malignant solid tumors, with emphasis on CRPC.\n\n          2. Patients must be 18 years of age or older.\n\n          3. Patients must have a Zubrod (ECOG) performance status of 0-2.\n\n          4. Patients must have an estimated survival of at least 3 months.\n\n          5. Any prior chemotherapy must have been completed at least 4 weeks prior to start of\n             treatment. Prior radiation must have been completed at least 2 weeks prior to start of\n             therapy. Patients must have recovered from acute reversible side effects of prior\n             chemotherapy regimens or radiotherapy to < grade 1 (excluding alopecia, lymphopenia,\n             and hyperglycemia) according to the National Cancer Institute Common Terminology\n             Criteria for Adverse Events (NCI-CTCAE), version 4.0.\n\n          6. Radiographs (Xrays, CT scans, etc) to follow disease response or progression must have\n             been completed within 28 days prior to registration.\n\n          7. Patients must have adequate renal function as documented by a calculated creatinine\n             clearance of > 45 ml/min (see Appendix for formula for calculating creatinine\n             clearance).\n\n          8. Patients must have adequate liver functions: AST and ALT < 2.5 X upper limit of\n             normal, and bilirubin < upper limit of normal.\n\n        Inclusion Criteria: MTD Expansion Phase Cohort 1 - CRPC\n\n          1. All patients must have a histologic diagnosis of adenocarcinoma of the prostate which\n             is measurable or non-measurable.\n\n          2. Patients must have metastatic prostate cancer deemed to be unresponsive or refractory\n             to hormone therapy by one or more of the following (despite androgen deprivation and\n             antiandrogen withdrawal when applicable):\n\n               -  Progression of measurable disease assessed within 28 days prior to registration.\n\n               -  Progression of non-measurable disease assessed within 28 days prior to\n                  registration.\n\n               -  Rising PSA - Rising PSA is defined as at least two consecutive rises in PSA to be\n                  documented over a reference value (measure 1). The first rising PSA (measure 2)\n                  must be taken at least 7 days after the reference value. A third confirmatory PSA\n                  measure is required (2nd beyond the reference level) to be greater than the\n                  second measure, and it must be obtained at least 7 days after the 2nd measure. If\n                  this is not the case, a fourth PSA is required to be taken and be greater than\n                  the second measure. The patient must have a PSA ? 5 ng/ml in addition to\n                  increasing PSA to be eligible by rising PSA criteria alone. However, no minimum\n                  PSA is required for patients whose progression is based on measurable or\n                  non-measurable disease.\n\n          3. All patients must have a pre-study PSA obtained within 28 days prior to registration.\n\n          4. All patients must have had imaging studies within 28 days prior to registration. The\n             choice of imaging studies to follow disease will be at the discretion of the\n             investigator.\n\n          5. Patients must be offered the opportunity to participate in specimen banking for future\n             use (to include the serum and tissue correlative studies).\n\n          6. Patients must have been surgically or medically castrated. If method of castration is\n             LHRH agonists (leuprolide or goserelin) or LHRH antagonists, then the patient should\n             be willing to continue the use of LHRH agonists. Patients who have stopped treatment\n             should be willing to restart.\n\n          7. If the patient has been treated with non-steroidal antiandrogens (flutamide,\n             bicalutamide, nilutamide or ketoconazole), they must have been stopped at least 14\n             days prior to registration for ketoconazole and at least 28 days prior to registration\n             for flutamide, bicalutamide or nilutamide and the patients must have demonstrated\n             progression.\n\n          8. Prior, planned, or ongoing bisphosphonate therapy or denosumab is allowed.\n\n        Exclusion Criteria:\n\n        (Dose-Escalation Phase)\n\n          1. Pregnant or breastfeeding women. The effects of these drugs on the unborn fetus are\n             unknown. Documentation of a negative serum pregnancy test is required for all women of\n             reproductive potential.\n\n          2. Patient has a clinically significant concurrent illness. Patients must not have a\n             serious intercurrent medical or psychiatric illness, including serious active\n             infection.\n\n          3. Patient is currently enrolled in a different clinical study in which investigational\n             procedures are performed or investigational therapies are administered. Also, a\n             patient may not enroll in such clinical trials while participating in this study.\n\n          4. Patient has a history of allergy or hypersensitivity to the study drugs or a taxane.\n\n          5. Patient has serious medical risk factors involving any of the major organ systems such\n             that the investigator considers it unsafe for the patient to receive an experimental\n             research drug.\n\n          6. Prior therapy with ADI-PEG 20 or docetaxel.\n\n          7. Allergy to pegylated compounds or study drugs.\n\n        Exclusion Criteria: MTD Expansion Phase Cohort 1 - CRPC\n\n          1. Patient has a clinically significant concurrent illness. Patients must not have a\n             serious intercurrent medical or psychiatric illness, including serious active\n             infection.\n\n          2. Patient is currently enrolled in a different clinical study in which investigational\n             procedures are performed or investigational therapies are administered. Also, a\n             patient may not enroll in such clinical trials while participating in this study.\n\n          3. Patient has a history of allergy or hypersensitivity to the study drug or a taxane.\n\n          4. Patient has serious medical risk factors involving any of the major organ systems such\n             that the investigator considers it unsafe for the patient to receive an experimental\n             research drug.\n\n          5. Prior therapy with ADI-PEG 20 or docetaxel.\n\n          6. Allergy to pegylated compounds.
+Adenocarcinoma of the prostate with locally advanced prostate cancer without distant metastatic with unfavorable risk features that are defined below: \r\n* Gleason Score >= 8; prostate-specific antigen (PSA) any; T-Stage any\r\n* Gleason Score 7; PSA >= 20; T-Stage any\r\n* Gleason Score 7; PSA any; T-Stage T3/T4
+Patients must have high-risk clinical stage D0 disease defined by the following:\r\n* In patients previously treated by prostatectomy, must have evidence of rising prostate specific antigen (PSA) with measurements at least two weeks apart, and final serum PSA value must be >= 2 ng/mL\r\n* In patients previously treated with ablative radiation therapy, an absolute increase in serum PSA by at least 2 ng/mL over nadir PSA value after radiation therapy\r\n* All patients must have at least four serum PSA values determined over a 12-week-to-six-month period of time prior to study entry from the same clinical laboratory; all available PSA values during this period (up to 6 months) will be used to calculate a PSA doubling time, according to the Memorial Sloan-Kettering Cancer Center nomogram\r\n* The PSA doubling time calculated from this nomogram, up to and including the value obtained at screening, must be < 12 months
+PSA > 2 ng/mL (at the time of enrollment or prior to initiation of docetaxel)
+Serum prostate specific antigen (PSA) < 10 ng/mL            \r\n* NOTE: baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors
+Histologically or cytologically proven prostate cancer with high risk for development of metastases, defined as either a PSA value >=8 ng/mL within the last 3 months or PSA Doubling Time <=10 months
+All patients must have evidence of biochemical progression as determined by a reference PSA value followed by 1 confirmatory rising PSA value, higher than the previous value, obtained at least 2 weeks apart; all of these PSA values must be obtained at the same reference lab, and all must be done within 6 months prior to enrollment
+The most recent of the PSA values must be >= 2.0 ng/ml; this measurement must be obtained within 1 month prior to enrollment
+The PSA doubling time (PSA-DT) must be less than 12 months
+serum prostate specific antigen (PSA) ?0.5 ng/mL and ?10 ng/mL;
+Pre-registration serum PSA level =< 100 ng/mL
+Demonstrated PSA progression within 12 weeks of study participation
+PSA progression according to PCWG2 criteria with 3 consecutive rising PSA measurements, all collected at least 1 week apart
+Evidence of disease progression (PSA progression, or radiographic/clinical progression [Prostate Cancer Working Group (PCWG2)])\r\n* PSA progression is defined as at least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, and each value >= 2.0 ng/mL\r\n* Radiographic progression is defined for soft tissue lesions using Response Evaluation Criteria in Solid Tumors (RECIST) criteria, i.e an increase greater than 20% in the sum of the longest diameter of all target lesions based on the smallest sum longest diameter since treatment started or the appearance of one of more new lesions with a confirmatory scan 6 or more weeks later; radiographic progression will be defined for bone lesions as the appearance of two new lesions with a confirmatory scan performed 6 or more weeks later that shows at least 2 or more additional new lesions
+Two consecutively rising PSA values or two out of three rising PSA values (2.0 ng/mL is the minimum ending value for PSA) at a minimum of 1-week intervals
+All patients must have a PSA >= 2 ng/mL
+Progressive disease based on any one of the following:\r\n* For patients with measurable disease, progression will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria\r\n* For patients with non-measurable disease, a positive bone scan and elevated PSA will be required; PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least one week apart; if the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA will be required to document progression for the purposes of eligibility\r\n* Radionuclide bone scan: new metastatic lesions\r\n* Patients whose sole manifestation of progression is an increase in disease-related symptoms are not eligible
+300 ng/mL < serum ferritin < 1,500 ng/mL (Values within 10% difference above 1500 ng/ml or 10% difference below 300 ng/ml may be accepted at the investigator's discretion.
+Prostate cancer with a current PSA level < 0.1 ng/mL.
+c. Biochemical recurrence following local therapy, either surgery or radiation. Rising PSA defined as:
+After radical prostatectomy, two PSA measurements of ? 1.0 ng/mL at least one week apart;
+After cryosurgery, two PSA measurements of ? 2.0 ng/mL at least one week apart;
+PSA doubling time (PSA-DT) of ? 3 months, using 2 PSA values at least 4 weeks apart, calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (https://www.mskcc.org/nomograms/prostate/psa-doubling-time);
+Rising PSA defined (PCWG2).
+A PSA value of at least 2 ng/mL is required at study entry.
+Biochemical disease progression after radical prostatectomy and/or radiation therapy (external-beam radiation therapy and/or brachytherapy), and no radiographic evidence of metastases\r\n* Men with history of radical prostatectomy are required to have baseline PSA > 0.5 ng/mL (prior treatment with neoadjuvant, adjuvant, or salvage radiation therapy is allowed, again, with screening PSA greater than or equal to 0.5 ng/mL required for eligibility)\r\n* Men treated with primary radiation therapy are required to have baseline PSA >= 1.0 ng/mL above their post radiation nadir for men who were treated with primary radiation therapy (external beam and/or brachytherapy); men who had primary radiation therapy followed by salvage prostatectomy are eligible if screening PSA is greater than or equal to 0.5 ng/mL\r\n* Men with previous neoadjuvant adjuvant hormone therapy are eligible if testosterone level at screening is non-castrate (>= 50 ng/dl); men previously treated with intermittent hormonal therapy are also eligible if level of testosterone at screening is non-castrate (>= 50 ng/dl)
+Curatively treated cervical intraepithelial neoplasia or prostate carcinoma with current prostate specific antigen (PSA) < 0.01 ng/mL; or
+Localized prostate cancer with at least one of the following National Comprehensive Cancer Network (NCCN) high-risk features:\r\n* Gleason sum >= 8\r\n* PSA > 20 ng/mL\r\n* Clinical stage >= T3
+PSA at least 2 ng/mL
+Patients must have evidence of disease progression during current or prior therapy with abiraterone with either:\r\n* Biochemical progression as defined as rising PSA by Prostate Cancer Clinical Trials Working Group (PCWG2) from a nadir or baseline (whichever was lowest) confirmed on a second determination at least 1 week later that must be higher than the first and must have reached >=2 ng/ml (if no other evidence of progression); or\r\n* New metastases on bone scan (at least 2); or\r\n* Progression of measurable disease on computed tomography (CT) scan by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
+Development of liver metastases in the absence of PSA progression as defined by PCWG2
+Biochemically relapsed disease with a rising PSA on at least two successive measurements at least two weeks apart after prior definitive local therapy (radical prostatectomy, external beam radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy (RT) with curative intent; if the confirmatory PSA value is less than the screening PSA value, then an additional test for rising PSA will be required to documents progression
+Minimum PSA:\r\n* If no prior androgen deprivation therapy (ADT) for biochemical relapse:\r\n** 1.0 ng/mL if prior radical prostatectomy with or without adjuvant/salvage radiation therapy, confirmed by repeat measurement at least 2 weeks later, or\r\n** Nadir + 2 ng/mL if prior RT alone without prior radical prostatectomy, confirmed by repeat measurement at least 2 weeks later\r\n* If prior ADT for biochemical relapse:\r\n** 4.0 ng/mL or > 2 ng/mL above nadir on prior cycle of ADT, whichever is higher, confirmed by repeat measurement at least 2 weeks later
+PSA doubling time (PSADT) =< 15 months, calculated based upon all serum PSA measurements obtained within 3 months prior to day 1 of protocol therapy, with a minimum of three PSA measurements spaced at least 14 days apart ; PSA values obtained when serum testosterone was known to be less than 150 ng/dL, prior to local therapy, or within three months of last dose of LHRH agonist/antagonist or antiandrogen will be excluded from the calculation of the PSADT
+Castrate-resistant disease, as evidenced by either:\r\n* Rising PSA on 2 consecutive measurements at least 2 weeks apart with concurrent documented serum testosterone < 50 ng/dL at the time of PSA measurement, or\r\n* Rising PSA on 2 consecutive measurements at least 2 weeks apart measured within 3 months after last LHRH agonist/antagonist injection
+PSA progression defined by a minimum of two rising PSA levels with an interval of ? 1 week between each determination. The PSA value at the Screening visit should be ? 2 ng/mL
+Patients will need to have documentation of metastatic disease in bone and/or soft tissue, and a baseline PSA of >= 5 ng/ml; patients with biochemical failures, with rising PSA (baseline PSA does not need to be >= 5 ng/ml to be eligible), without metastatic disease are also eligible if castration therapy is indicated for a minimum of 7 months and for these patients any PSA value is permitted
+Metastatic castration resistant prostate cancer as defined by serum testosterone < 50 ng/ml and one of the following:\r\n* Prostate specific antigen (PSA) level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart\r\n* Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors) \r\n* Progression of metastatic bone disease on bone scan with > 2 new lesions
+Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ?2 new bone lesions
+Serum prostate specific antigen equal to or less than 10 ng/mL
+Have a PSA less than 10 ng/mL,
+Have a PSA density less than 0.15 ng/ml/cc,
+Have a PSA velocity less than 2 ng/ml yearly in the year prior to diagnosis,
+Biochemical recurrence following prostatectomy or radiation to the prostate, defined as at least 3 PSA rises, with each PSA determination at least 4 weeks apart, and each PSA value >= 0.2 ng/mL
+PSA must be < 50 ng/mL at study entry
+Screening PSA >= 0.5 ng/mL for men who had a prostatectomy; prior treatment with neoadjuvant, adjuvant or salvage radiation therapy is allowed, again, with screening PSA >= 0.5 ng/mL required for eligibility
+Screening PSA >= 1.0 ng/mL above their postradiation nadir for men who were treated with primary radiation therapy (external beam and/or brachytherapy); men who had primary radiation therapy followed by salvage prostatectomy are eligible if screening PSA >= 0.5 ng/mL
+PSA doubling time between 3 and 36 months
+Prostate cancer, with organ-localized disease with very low risk of disease recurrence, as indicated by stage pT2, N0, M0 lesions (if American Joint Committee on Cancer [AJCC] staging is not available in medical records, the investigators will infer the staging based on extensive review of the pathology report), combined Gleason score of 7 (3+4) or less, and preoperative PSA < 10 ng/ml
+Stable and undetectable PSA level (PSA < 0.1 ng/mL using an assay that has a functional sensitivity of 0.1 ng/mL) for at least two years after radical prostatectomy
+Known progressive castration-resistant disease, defined as: \r\n* Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first treatment, each measurement at least one week apart; serum PSA at screening >= 2 ng/mL; or \r\n* Documented appearance of new lesions by bone scintigraphy
+Prostate-specific antigen (PSA) level of 0.1 - 50 ng/dl
+PSA > 50 ng/dl
+PSA < 0.5 ng/dL
+Detectable PSA, defined as PSA >= 0.01 ng/ml
+Patients must have the following features:\r\n* Gleason >= 4+3 = 7 OR\r\n* Gleason 3+4 = 7 AND at least one of the following: PSA > 20 ng/mL, or T3 disease (as determined by MRI)
+Rising PSA after prostatectomy or radiation with PSA doubling time =< 6 months
+Persistent PSA after prostatectomy for PSA >= 0.2 ng/mL
+Vitamin D insufficiency, defined as 25(OH)D =< 32 ng/ml
+Ferritin >= 800 ng/mL
+Prostate-specific antigen (PSA) >= 0.2 ng/ml
+Diagnostic prostate specific antigen (PSA) =< 10 ng/ml
+A priori, we will allow men with concurrent benign prostatic hyperplasia (prostate volume > 50 g) to have a PSA between 10-15 ng/ml; and include men with low volume Gleason 3+4 disease, because such men have similar outcomes on active surveillance to those with Gleason =< 3+3
+Serum vitamin D level >= 10 ng/ml
+PSA of 2-10 ng/mL
+25(OH)D3 level less than 20 ng/ml prior to stage 2 initiation
+Post-operative prostate-specific antigen (PSA) < 0.2 ng/mL by 120 days after prostatectomy
+Must have one or more of the following:\r\n* pT3b or pT4 primary tumor\r\n* Gleason score 8-10\r\n* pN1 lymph node disease\r\n* Positive surgical margins\r\n* Pre-operative PSA of >= 10 ng/mL
+PSA < 25
+Have a PSA < 25
+Screening serum PSA < 20 ng/mL; for men treated with 5-alpha-reductase inhibitors (e.g., finasteride, dutasteride), PSA needs to be < 10 ng/mL
+Participants must have had a standard-of-care biopsy within 13 months of the baseline study visit and must have been diagnosed with low-grade, clinically localized prostate cancer (Gleason score =< 3+3 with a PSA at baseline < 10 ng/ml in participants < 70 years of age, OR Gleason score =< 3+4 with a PSA at baseline =< 15 ng/ml in participants >= 70 years of age); eligible participants will be those men who are able and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the end of the study
+Documented progressive metastatic CRPC based on at least one of the following criteria:\r\n* PSA progressive defined as 25% increased over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL\r\n* Soft-tissue progression defined as an increase >= 20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions\r\n* Progression of bone disease (evaluable disease) or (new bone lesion[s]) by bone scan
+PSA within the past 2 months is between 3 and 20 ng/ml if patient received local radiation OR between 0.4 and 20 ng/ml if patient received prior radical prostatectomy
+Patient with PSA less than or equal to 20 ng/mL
+At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ?T3a or PSA >20 ng/mL or Gleason score ?8).
+COHORT I: Biochemical recurrence defined as any of the following:\r\n* PSA >= 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients treated with surgery, radiation therapy, brachytherapy, or cryotherapy\r\n* PSA >= 0.2 ng/ml above the most recent therapy nadir for patients who have received additional treatment in the recurrent setting
+Detectable prostate-specific antigen (PSA)
+Prostate-specific antigen (PSA) >= 0.1 ng/ml at time of enrollment.
+Proven biochemical recurrence as defined by American Urological Association (AUA) recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after radical prostatectomy
+PSA values ranging from 0.2 ng/mL to 2 ng/mL
+Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)\r\n* Post radical prostatectomy (RP) – American Urological Association (AUA) recommendation\r\n** PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,\r\n** Confirmatory persistent PSA greater than 0.2 ng/mL\r\n* Post-radiation therapy –American Society for Therapeutic Radiology and Oncology (ASTRO) (ASTRO)-Phoenix consensus definition\r\n** Nadir + greater than or equal to 2 ng/mL rise in PSA
+Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)\r\n* If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association [AUA] recommendation for biochemical recurrence)\r\n* If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society for Radiation Oncology [ASTRO] recommendation for biochemical recurrence)
+Rising PSA (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)\r\n* Post radical prostatectomy (RP) – American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy\r\n** PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP\r\n* Post-radiation therapy–American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition of biochemical recurrence after radiation therapy\r\n** Nadir + greater than or equal to 2 ng/mL rise in PSA
+SUB-STUDY II: Biochemical recurrence with PSA > 0.2 ng/mL on two successive tests
+SUB-STUDY III: Two consecutive rising PSA values
+Patients fit criteria for one of the following categories:\r\n* COHORT 1\r\n** Known localized high risk prostate cancer (PSA > 10, Gleason 8-10 or clinical stage > T2c) with evidence of disease on standard imaging or\r\n* COHORT 2\r\n** Nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA >= 0.2 ng/mL
+Prostate carcinoma patients at high risk for metastasis with prostate–specific antigen (PSA) more than 20 ng/ml and/or Gleason score = 8/ > 8.
+Unfavorable risk intermediate prostate cancer eligible for standard of care surgery\r\n* Grade group 2 (Gleason score 3+4) with either PSA 10 - < 20 or clinical stage T2b-c, OR grade group 3 (Gleason 4+3) with PSA < 20
+Persistently elevated PSA
+Rising PSA after definitive therapy with prostatectomy or radiation therapy.\r\n* Post radical prostatectomy (RP)\r\n** PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP\r\n* Post-radiation therapy – American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition\r\n** Nadir + greater than or equal to 2 ng/mL rise in PSA
+Prostate specific antigen (PSA) measurement =< 42 days prior to study enrollment
+Patients must have rising serum PSA level defined as at least 2 consecutive rises in PSA documented over a reference value; the first rising PSA (2nd measure) should be taken at least 14 days after the reference value; a confirmatory PSA measure (3rd measure) obtained at least 14 days after the 2nd measure is required and must be greater than the 2nd measure; initial (reference) PSA must be >= 4 and the two consecutive rises must all be >= 0.5 over the previous PSA measure
+Elevated PSA level (>= 4) and a prior negative standard biopsy of the prostate
+PSA < 0.1 ng/ml at enrollment
+Patient will have suspicion of recurrent prostate carcinoma as defined by: older American Society for Radiation Oncology (ASTRO) criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 ng/ml (ASTRO-Radiation Therapy Oncology Group [RTOG] Phoenix criteria)
+Patients must have histopathology confirmed prostate cancer that is Gleason score =< 7 (4+3) clinical stage =< T2aN0M0 with a PSA below 15 ng/mL
+PSA >= 15 ng/mL
+Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy\r\n* Post radical prostatectomy (RP) – American Urological Association (AUA) recommendation\r\n** PSA greater than 0.2 ng/mL measured 6–13 weeks after RP\r\n** Confirmatory persistent PSA greater than 0.2 ng/mL\r\n* Post-radiation therapy – American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition \r\n** Nadir plus (+) greater than or equal to 2 ng/mL rise in PSA
+PSA < 25 ng/mL
+Serum prostate specific antigen (PSA) =< 20 ng/ml within 3 months of study enrollment
+Patients with moderate to high-risk disease as defined by D' Amico risk stratification and having at least one of the following:\r\n* Prostate-specific antigen (PSA) level > 10 ng/ml\r\n* Gleason score >= 7\r\n* Clinical stage >= T2c
+Rising PSA on two observations taken at least 1 week apart
+Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
+Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)\r\n* Post radical prostatectomy (RP) – American Urology Association (AUA) recommendation\r\n** PSA greater than 0.2 ng/mL measured 6–13 weeks after RP\r\n** Confirmatory persistent PSA greater than 0.2 ng/mL\r\n* Post-radiation therapy –American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition\r\n** Nadir + greater than or equal to 2 ng/mL rise in PSA
+Prostate-specific antigen (PSA) within 4 months prior to study consent or within 30 days after study consent < 10 ng/mL
+Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following:\r\n* Rising PSA over a minimum 1-week interval\r\n* Radiographic progression in soft tissue and/or bone
+Serum PSA level >= 0.2 ng/mL at least 45 days prior to study enrollment
+Two PSA values >= 0.2 ng/mL at least 4 weeks after prostatectomy
+PSA recurrence not verified by elevated PSA as discussed in the eligibility section
+Patient will have suspicion of recurrent prostate carcinoma as defined by: the American Society for Therapeutic Radiology and Oncology (ASTRO)-Radiation Therapy Oncology Group (RTOG) Phoenix criteria of elevated prostate-specific antigen (PSA) greater than nadir plus 2 ng/ml with absolute PSA >= 4.0 ng/ml with any doubling time (DT) or with PSA 2.0-3.99 ng/ml with DT =<10 months
+Does not meet above criteria of suspicious PSA elevation
+Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)\r\n* Post radical prostatectomy (RP) – American Urological Association (AUA) recommendation\r\n** PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and\r\n** Confirmatory persistent PSA greater than 0.2 ng/mL\r\n* Post-radiation therapy –American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition\r\n* Nadir + greater than or equal to 2 ng/mL rise in PSA
+Patient has suspected recurrence based on biochemical data (prostate-specific antigen [PSA] > 2 ng/mL)
+PSA < 10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
+PSA levels to be taken within 2 weeks of antibody administration
+Abnormal prostate-specific antigen (PSA) blood test\r\n* > 2.5 ng/mL for men < 50 years (yrs) of age\r\n* > 3.5 ng/mL for men < 60 yrs of age\r\n* > 4.5 ng/mL for men < 70 yrs of age
+Prostate specific antigen (PSA) < 10 ng/mL
+ARM II ONLY: For patients status post prostatectomy, a PSA >= 0.2 ng/ml
+Serum PSA ? 20ng/ml within the previous 3 months
+Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
+Post non-prostatectomy: PSA rise ? 2ng/mL over nadir
+Patient has suspected recurrence based on biochemical data (prostate specific antigen [PSA] > 2 ng/mL)
+Increased PSA level >4 ng/mL
+Detectable PSA, defined as PSA detectable and rising on 2 or more subsequent determinations
+Failure of PSA to nadir after surgery
+biochemical progression (PSA)
+Abnormal serum PSA (total > 2.5 ng/ml or other clinically important biomarker parameters, including PSA velocity and density) associated with or without normal digital rectal examination
+Patients must have progressive prostate cancer as indicated by either PSA progression (PSA progression is defined as two consecutively rising PSAs above the nadir post-definitive therapy and an absolute value greater than 1.0 ng/mL separated by at least 2 weeks) or radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or Prostate Cancer Working Group 3 (PCWG3).
+A rise in prostate-specific antigen (minimal value 2 ng/milliliter (mL); ?3 consecutive rising values)
+Prostate-specific antigen (PSA) < 50 ng/mL
+PSA<50
+PSA > 20
+At least 2 of the following 3 factors: Gleason score(GS) 3+4=7 and/or PSA 10-20 and/or T2b/c
+Baseline serum PSA value performed with an FDA-approved assay within 120 days prior to registration. Study entry PSA should not be obtained within 10-day period following prostate biopsy or following initiation of hormonal therapy