PSA at screening must be ? g/L.
Last PSA value should have increase of ? % of the first PSA value and an absolute increase of ? ng/mL over the first PSA value
Prostate- specific antigen (PSA) Progression: An elevated PSA ? ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA < PSA < PSA). If the rd PSA value is less than the nd 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 relapse within  years of prostatectomy defined by persistently detectable or rising PSA after surgery
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)
Biochemical progression (rising PSA) after medical or surgical castration
Rising PSA as defined above and either:
PSA doubling time <  months
Evidence of rising PSA, on  separate occasions, at least one week apart; baseline PSA must be >= . 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  PSA levels within a six month period) to calculate a baseline PSA doubling time
Biochemically recurrent prostate cancer with PSA doubling time ?  months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past  months prior to randomization, with a minimum of  values separated by at least  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)
Patients must be withdrawn from abiraterone for >=  weeks and have documented PSA increase after the  week withdrawal period
Prostate specific antigen (PSA) < , within  months of study entry\r\n* Participants who are currently receiving dutasteride (or have received it within the last  days) or finasteride (or have received it within the last  days) must have a PSA of =< 
PSA doubling time of <  months, measured over the  months prior to enrollment
No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated to r/o metastatic disease if clinical T and PSA >  or T and PSA > 
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 >= . ng/mL\r\n* For radiation therapy the threshold is a PSA rise of  ng/mL above the nadir PSA achieved post radiation with or without hormone therapy ( 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  and  months; PSA calculation requires at least two consecutive PSA rises (PSA and PSA) above the threshold PSA (at least  PSA values); PSA and PSA must be obtained within  months of study entry; all baseline PSAs should be obtained at the same reference laboratory (lab); patient's PSA doubling time must be calculated
PSA doubling time (PSADT) >=  months and =<  months:\r\n* Patients must have >=  PSA measurements over >=  months\r\n* The interval between PSA measurements must be >=  weeks
Progressive disease by PSA or imaging after most recent prior therapy. PSA ? 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  measurements obtained ?  week apart.
Two rising PSA values separated by at least  week, one showing a rise of at least . ng/mL and one confirmatory value not showing a decline, while on abiraterone therapy.
Patients must have a rising PSA as confirmed by  values a minimum of  week apart over at least a  month period of time
Patients must have a PSA doubling time of - months
PSA relapse within  years of prostatectomy defined by persistently detectable or rising PSA after surgery
PSA failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least  ng/dL above post-radiotherapy nadir)
A minimum of  rising PSA values with an interval of at least  week between determinations. The screening central laboratory PSA value must be ?  ?g/L ( ng/mL) if qualifying solely by PSA progression.
Prostate-specific antigen (PSA) progression: minimum of  rising values ( measurements) obtained a minimum of  days apart with the last result being at least >/= . ng/mL;
Have received at least  cycles of docetaxel or cabazitaxel, and less than ten, with two consecutive rising PSA values, checked at least  days apart
PSA progression defined by a minimum of two rising PSA levels with an interval of >=  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 >=  week between each determination such that at least the second of these rises is >  weeks since last flutamide or >  weeks since last bicalutamide or nilutamide; the PSA value at the screening should be >  ug/L ( 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  days prior to initial administration of drug\r\n* Progression of evaluable but not measurable disease assessed within  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 ); the first rising PSA (measure ) should be taken at least  days after the reference value; a third confirmatory PSA measure (nd beyond the reference level) should be greater than the second measure, and it must be obtained at least  days after the nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
PSA blood test within  days prior to registration
Subjects with a rising PSA value >  ng/mL in at least  measurements, at least  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  days prior to initial administration of drug\r\n* Progression of evaluable but not measurable disease assessed within  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 ); the first rising PSA (measure ) should be taken at least  days after the reference value; a third confirmatory PSA measure (second [nd] beyond the reference level) should be greater than the second measure, and it must be obtained at least  days after the nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
Evidence of rising PSA on ADT
PSA >= . after radical prostatectomy (value w/in  months of registration) AND at least  unfavorable risk factor listed below\r\n* Gleason -\r\n* PSA > .\r\n* Pathologically positive lymph nodes\r\n* pT or pT\r\n* PSA doubling time (DT) <  months\r\n* Negative margins\r\n* Persistent PSA after radical prostatectomy (RP) (PSA never dropped below . after RP)\r\n* Local/regional recurrence on imaging\r\n* Decipher high risk (a Medicare-reimbursed test for risk of metastases after prostatectomy)
One of the following pathologic classifications\r\n* TN disease with or without a positive surgical margin or\r\n* TN disease with or without a positive surgical margin\r\n** Those with TN 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 . ng/mL or greater
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  days prior to initial administration of drug\r\n* Progression of evaluable but not measurable disease assessed within  days prior to initial administration of drug for PSA evaluation and within  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 ); the first rising PSA (measure ) should be taken at least  days after the reference value; a third confirmatory PSA measure (nd beyond the reference level) should be greater than the second measure, and it must be obtained at least  days after the nd 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
Patients with rising PSA on two successive measurements at least  weeks apart
Most recent PSA value more than  months ago
PSA Doubling time <  months after local therapy in patients who have not had any previous hormone therapy
A minimum of three PSA values, each at least  weeks apart, to calculate PSA-doubling time (DT); the last PSA level prior to enrollment must be at least . ng/mL and be rising over the prior value
PSA must be at least  ng/ml and rising on two successive measurements at least two weeks apart
Progressive, castration-resistant prostate cancer demonstrated during continuous antiandrogen therapy (ADT), defined as  PSA rises at least  week apart, with the last PSA >  ng/mL
Patients who received a first generation anti-androgen (e.g., bicalutamide, flutamide, nilutamide) as most recent treatment must have at least a -week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after washout
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  days prior to initial administration of drug\r\n* Progression of evaluable but not measurable disease assessed within  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 ); the first rising PSA (measure ) should be taken at least  days after the reference value; a third confirmatory PSA measure (nd beyond the reference level) should be greater than the second measure, and it must be obtained at least  days after the nd 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  rising PSA levels with an interval of >= week between each determination. The PSA value at screening must be >= microgram (g)/L ( ng/mL) if PSA is the only indication of progression; subjects on systemic glucocorticoids for control of symptoms must have documented PSA progression by PCWG while on systemic glucocorticoids prior to commencing Cycle  Day  treatment.
PSA is mandatory (<  days prior to registration)
Patients must have rising PSA on two successive measurements, at least  weeks apart
Subjects must have castrate levels of testosterone (? ng/dl [. nmol/L]) and have progressive disease at Screening defined as PSA rise determined by a minimum of  rising PSA values ? week between each assessment. The PSA value at the Screening visit must be ?ng/mL with or without:
PSA doubling time ?  months;
PSA doubling time ?  months;
Increasing PSA level: at least two consecutive rising PSA values over a reference value (PSA #) taken at least  week apart. A third PSA (PSA #) is required to be greater than PSA #; if not, a fourth PSA (PSA #) is required to be greater than PSA #. 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 #) taken at least  week apart. A third PSA (PSA #) is required to be greater than PSA #; if not, a fourth PSA (PSA #) is required to be greater than PSA #.
PSA blood test within  days prior to registration
Baseline serum PSA value performed with an Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within  days prior to registration\r\n* Study entry PSA must not be obtained during the following time frames: () -day period following prostate biopsy; () following initiation of ADT; () within  days after discontinuation of finasteride; or () within  days after discontinuation of dutasteride
Prostatic specific antigen doubling time (PSADT) <  months; PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA > .); to calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used
PSA >= . but =< 
Patients must have a PSA doubling time of - months
Patients must have a rising PSA as confirmed by  values done at least  week apart and over no less than  month
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 . ng/mL, determined by two measurements, at least  month apart and at least  months after prostatectomy OR\r\n* PSA values for patients after radiation must be greater than or equal to . ng/ml greater than the nadir achieved after radiation, determined by two measurements at  month apart and at least  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 .)\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  months
Progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (PSA) values (PSA < PSA < PSA);
The serum PSA should be less than or equal to  ng/ml; study entry PSA must not be obtained during the following time frames: () -day period following prostate biopsy; () following initiation of androgen deprivation therapy (ADT); () within  days after discontinuation of finasteride; or () within  days after discontinuation of dutasteride
Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a -week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period
Rising serum PSA levels documented by  values over the last  months prior to study enrollment. Each value must be greater than  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 >=  week apart
COHORT B: Histologically confirmed prostate cancer with progressive disease, defined as:\r\n* Rising PSA (% or more increase to a level of  ng/mL or more, based on at least  PSA determinations obtained at least  week apart); the % rise in PSA is across the  determinations, and these determinations do not need to be sequential\r\n* PSA doubling time of =<  months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram
Prostate-Specific Antigen (PSA) progression defined by a minimum of  rising PSA levels with an interval of at least  week between each draw;
Patients must have evidence of biochemical (PSA) relapse after prostatectomy, defined by one rise in PSA above a baseline detectable value (>= . ng/mL) using measurements taken at least  weeks apart from each other (all PSA values must be within  months of study entry)
Castration-resistant prostate cancer demonstrated during continuous ADT, defined as  PSA rises, at least  week apart, with the last PSA greater than (>)  nanogram per milliliter (ng/mL)
Patients who received a first generation anti-androgen (for example, bicalutamide, flutamide, nilutamide) must have at least a -week washout prior to randomization AND must show continuing disease (PSA) progression (an increase in PSA) after washout
Prostate specific antigen (PSA) value can be undetectable up to a value of . within  days prior to study entry
Patient must have a histological diagnosis of adenocarcinoma of the prostate and  rising pre-study PSA values >=  ng/ml at least  week apart within  days prior to enrollment
Patients must have a PSA doubling time of  months or less
Patients must have a rising PSA as confirmed by  values done at least  week apart and over no less than  month
Evidence of disease progression on ADT. Patients must have two serial rises in PSA from nadir, with at least  week between PSA measurements, with a minimum PSA of  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  months
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 ., 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 ., with a subsequent measurement >. ng/mL
Histologically confirmed prostate cancer (per standards at institution of participant registration) currently with progressive disease, defined as:\r\n* Rising PSA (% or more increase to a level of  ng/mL or more, based on at least  PSA determinations obtained at least  week apart); the % rise in PSA is across the  determinations, and these determinations do not need to be sequential; AND\r\n* Prostate-specific antigen doubling time (PSADT) =<  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 >=  serum PSA values obtained over at least a  week period of time prior to registration, including the day of screening, to calculate a PSA doubling time; Note: PSAs are not required to be obtained at the same laboratory; use all PSA values that have been done in last  months to calculate PSA doubling time
Patient must have biochemical evidence of prostate-specific antigen (PSA) including one of the following:\r\n* Biochemical recurrence (defined as nadir +  rises measured at least  weeks apart)\r\n* PSA doubling time of less than or equal to  months OR\r\n* Persistently elevated PSA (PSA post prostatectomy of . ng/mL if standard assay or greater than . if ultrasensitive PSA assay)
Patients must have high-risk clinical stage D 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 >=  ng/mL\r\n* In patients previously treated with ablative radiation therapy, an absolute increase in serum PSA by at least  ng/mL over nadir PSA value after radiation therapy\r\n* All patients must have at least four serum PSA values determined over a -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  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 <  months
Histologically or cytologically proven prostate cancer with high risk for development of metastases, defined as either a PSA value >= ng/mL within the last  months or PSA Doubling Time <= months
Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesicle involvement, provided all visible disease was surgically removed) that have completed local therapy and have an elevated PSA after surgery or rising PSA after radiation therapy
All patients must have evidence of biochemical progression as determined by a reference PSA value followed by  confirmatory rising PSA value, higher than the previous value, obtained at least  weeks apart; all of these PSA values must be obtained at the same reference lab, and all must be done within  months prior to enrollment
The PSA doubling time (PSA-DT) must be less than  months
Demonstrated PSA progression within  weeks of study participation
PSA progression according to PCWG criteria with  consecutive rising PSA measurements, all collected at least  week apart
Two consecutively rising PSA values or two out of three rising PSA values (. ng/mL is the minimum ending value for PSA) at a minimum of -week intervals
c. Biochemical recurrence following local therapy, either surgery or radiation. Rising PSA defined as:
PSA doubling time (PSA-DT) of ?  months, using  PSA values at least  weeks apart, calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (https://www.mskcc.org/nomograms/prostate/psa-doubling-time);
Previous inclusion in the study (e.g., a patient who has had negative TRUS and MRI-guided biopsies but continues to have a rising PSA)
Rising PSA defined (PCWG).
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
PSA doubling time (PSADT) =<  months, calculated based upon all serum PSA measurements obtained within  months prior to day  of protocol therapy, with a minimum of three PSA measurements spaced at least  days apart ; PSA values obtained when serum testosterone was known to be less than  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  consecutive measurements at least  weeks apart with concurrent documented serum testosterone <  ng/dL at the time of PSA measurement, or\r\n* Rising PSA on  consecutive measurements at least  weeks apart measured within  months after last LHRH agonist/antagonist injection
PSA progression defined by a minimum of two rising PSA levels with an interval of ?  week between each determination. The PSA value at the Screening visit should be ?  ng/mL
Patients will need to have documentation of metastatic disease in bone and/or soft tissue, and a baseline PSA of >=  ng/ml; patients with biochemical failures, with rising PSA (baseline PSA does not need to be >=  ng/ml to be eligible), without metastatic disease are also eligible if castration therapy is indicated for a minimum of  months and for these patients any PSA value is permitted
Biochemical recurrence following prostatectomy or radiation to the prostate, defined as at least  PSA rises, with each PSA determination at least  weeks apart, and each PSA value >= . ng/mL
PSA doubling time between  and  months
Rising PSA after prostatectomy or radiation with PSA doubling time =<  months
PSA < 
Have a PSA < 
SUB-STUDY III: Two consecutive rising PSA values
Persistently elevated PSA
Patients must have rising serum PSA level defined as at least  consecutive rises in PSA documented over a reference value; the first rising PSA (nd measure) should be taken at least  days after the reference value; a confirmatory PSA measure (rd measure) obtained at least  days after the nd measure is required and must be greater than the nd measure; initial (reference) PSA must be >=  and the two consecutive rises must all be >= . over the previous PSA measure
Rising PSA on two observations taken at least  week apart
PSA recurrence not verified by elevated PSA as discussed in the eligibility section
PSA levels to be taken within  weeks of antibody administration
Detectable PSA, defined as PSA detectable and rising on  or more subsequent determinations
Failure of PSA to nadir after surgery
biochemical progression (PSA)
A history of antibiotic use within one month prior to initial PSA level measurement
PSA<
PSA > 
Baseline serum PSA value performed with an FDA-approved assay within  days prior to registration. Study entry PSA should not be obtained within -day period following prostate biopsy or following initiation of hormonal therapy