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
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
Subject has high-risk features (e.g., based on Gleason score, PSA, clinical stage, % positive biopsies), and the treating physician feels the subject should undergo radical prostatectomy sooner than planned within the protocol
Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
Must be considered either low-risk (T1-T2a, Gleason =< 6, prostate specific antigen [PSA] < 10 ng/mL) or favorable intermediate-risk (Gleason 3 + 4 = 7, percentage of positive biopsy cores < 50%, no more than one National Comprehensive Cancer Network [NCCN] intermediate risk factor)
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
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
Subjects must have the diagnosis of prostate cancer and be on active surveillance (AS). For the purpose of this study, active surveillance implies prostate-specific antigen (PSA) < 10 ng/mL, biopsy Gleason sum =< 6 with no pattern 4 or 5, cancer involvement of < 33% of biopsy cores, and clinical stage T1/T2a tumor.
The following tumor stage and Gleason scores: a) clinical >= stage T1c/T2 tumor with Gleason score >=8 b) clinical stage >= T2b tumor with Gleason score >= 7 and PSA > 10 ng/ml.
Histologically proven adenocarcinoma of the prostate and: Gleason > 8 OR prostatic specific antigen (PSA) > 20 and more than 1 positive core
High risk prostate cancer (per National Comprehensive Cancer Network [NCCN] criteria): Gleason score 8-10 or T3a or PSA > 20 ng/mL or very-high risk prostate cancer (per NCCN criteria): T3b-T4
Poor prognosis disease as defined by any of the following:\r\n* PSA nadir >=4.0, or\r\n* Gleason score 8-10, or\r\n* Time from ADT initiation to CRPC of =< 16 months
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)
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
Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group:\r\n* High risk:\r\n** Clinical stage T3a, or Gleason score = 8-10, or PSA > 20 ng/mL
Pathological diagnosis of adenocarcinoma of the prostate, judged to be at high risk for recurrence based on any of the following (in accordance with the International Society of Urological Pathology (ISUP) Consensus 2005: Gleason score 8-10 OR Gleason score of 4+3 AND clinical T2b-4 AND PSA >20ng/mL OR N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or biopsy proven
Patients must have at least one of the following criteria:\r\n* The serum PSA should be greater than or equal to 20 ng/ml OR study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of antiandrogen therapy (ADT)\r\n* The Gleason score should be greater than or equal to 8 OR\r\n* Eligible patients must have appropriate staging studies identifying them as American Joint Committee on Cancer (AJCC) stage T3+ adenocarcinoma of the prostate gland; (MR stage T3a without other high risk factors permitted at investigator discretion)
Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:\r\n* Pre-biopsy prostate-specific antigen (PSA) >= 20\r\n* Biopsy Gleason score 8-10\r\n* Clinical stage T3
pT1-pT3pNxMx patients in whom standard National Comprehensive Cancer Network (NCCN) or American Urology Association (AUA) guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease; this includes patients with Gleason 6 or 7 (T2 disease) and prostate-specific antigen (PSA) less than 20
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
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
National Comprehensive Cancer Network (NCCN) risk category very low, low, or intermediate risk:\r\n* Combined Gleason score =< 7\r\n* Prostate specific antigen (PSA) within three months of enrollment < 20 ng/ml\r\n* Clinical stage T1a-cN0M0 or clinical stage T2aN0M0
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.
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)
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
Inclusion Criteria include:\n\n          -  Histologically confirmed adenocarcinoma of the prostate\n\n          -  Patients choosing active surveillance\n\n          -  Patients meeting definition of NCCN low risk, intermediate risk OR patients having\n             only one NCCN high-risk feature\n\n               -  NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason\n                  ? 6, T1-T2a\n\n               -  NCCN Intermediate Risk is defined as having at least one of the following and no\n                  high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c\n\n               -  High Risk with a single high risk feature is defined as having only one of the\n                  following: PSA>20 ng/ml, Gleason score 8-10, or T3a\n\n               -  Excluded are those in the following risk groups: High risk with more than 1 high\n                  risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1\n\n          -  Patients must be planning and medically able to tolerate multiple transrectal\n             ultrasound guided injections.\n\n          -  ECOG Performance status 0-2\n\n        Exclusion Criteria include:\n\n          -  Active liver disease, including known cirrhosis or active hepatitis\n\n          -  Patients on systemic corticosteroids (>10 mg prednisone per day) or other\n             immunosuppressive drugs\n\n          -  Known HIV+ patients\n\n          -  Regional lymph node involvement or distant metastases\n\n          -  Other current malignancy (except squamous or basal cell skin cancers)\n\n          -  Other serious co-morbid illness or compromised organ function that, in the opinion of\n             the investigator, would interfere with treatment or follow up\n\n          -  Prior treatment for prostate cancer except TURP. If prior TURP, patients must be\n             deemed able to receive prostate biopsy and multiple intra-prostatic injections by the\n             investigator\n\n          -  Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)\n\n          -  Patients who had or plan to use ADT or have history of an orchiectomy.\n\n          -  Patients who are planning to undergo radical treatment for prostate cancer within 12\n             months.\n\n          -  Known sensitivity or allergic reactions to acyclovir or valacyclovir
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
Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic\r\nT?stage 3?4 disease, pathologic Gleason score 8?10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate?specific antigen on at least two consecutive draws, with the magnitude of\r\nprostate?specific antigen exceeding 0.03 ng/mL
Have progressive advanced prostate cancer based on at least one of the following criteria:\r\n* Gleason score of ? 7\r\n* Any PSA\r\n* TNM clinical stage T3-T4, N1
At least one of the following:\r\n* Two or more high risk features OR\r\n** Gleason score 8-10\r\n** PSA >= 20 ng/mL within two months prior to registration\r\n** Clinical stage >= T3 disease, as determined by standard digital rectal examination (DRE)\r\n** Radiographic stage >= T3 disease as determined by a >= 75% probability of extracapsular extension or seminal vesicle invasion per reading radiologist\r\n* Any Gleason 9 or 10 disease OR\r\n* > 4 cores of Gleason 8 disease
Subjects must have one of the following risk factors:\r\n* Prostate-specific antigen (PSA) >= 20 and/or\r\n* Gleason score >= 8 and/or\r\n* Clinical or radiographic stage >= T3a per American Joint Committee on Cancer (AJCC) 7th Edition Staging Manual and/or\r\n* Radiographic pelvic lymph node positive disease and/or\r\n* At least two out of four of the following: PSA 10-19.9, Gleason score (GS) = 3+4, clinical stage = T2b/T2c, >= 50% positive biopsy cores
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
Patients must have low- or intermediate-risk adenocarcinoma of the prostate as defined by:\r\n* Low-risk disease\r\n** Histopathology score (Gleason sum): =< 6, and T-stage (per current American Joint Committee on Cancer [AJCC] staging criteria): T1c-T2a, and prostate-specific antigen (PSA) < 10\r\n* Intermediate-risk disease as either:\r\n** Histopathology score (Gleason sum): =< 6, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA: > 10 but =< 20 Or\r\n** Histopathology score (Gleason sum): 7 with =< 50% cores positive, T-stage (per current AJCC staging criteria): T1c-T2a, and PSA < 10
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 with prostate cancer on active surveillance at low risk for progression, defined as Prostate-Specific Antigen (PSA) < 10 ng/dL, Gleason score 6 and clinical stage tumor-1 (cT1) are permitted to be in the study at the discretion of the investigator (see exclusion criterion 10).
A history of prostate cancer that was identified incidentally following cystoprostatectomy for bladder cancer is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score ?6; Prostate-specific Antigen (PSA) level undetectable.
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)
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
Prostate adenocarcinoma without distant metastatic disease with either Gleason score >= 7, PSA >= 10 ng/ml, or T2b or greater disease
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
Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: \r\n* Gleason score 7\r\n* Prostate specific antigen (PSA) > 10 but =< 20\r\n* Clinical stage T2b-T2c\r\n* Patients previously diagnosed with low risk (Gleason score =< 6, clinical stage < T2a, and PSA < 10) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure
Prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
Intermediate risk prostate cancer patients will be eligible for this study; intermediate risk grouping will be assessed per National Comprehensive Cancer Network (NCCN) guidelines as: \r\n* Pathologically-proven diagnosis of prostate adenocarcinoma\r\n* PSA 10-20 ng/mL or\r\n* Gleason = 7 or\r\n* Clinical stage T2b/c
Participants must have the following features:\r\n* Intermediate-risk disease defined as Gleason 4+3 = 7 disease OR\r\n* High-risk disease defined as Gleason 8-10 OR PSA > 20 ng/mL OR T3 disease (by prostate MRI)
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
Patients previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA < 10) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure
Diagnosed with prostate cancer, T1-T2bN0M0 Gleason score (GS) 6-7; prostate specific antigen (PSA) < 20
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)
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%
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
Biopsy proven intermediate risk prostate cancer, which includes patients with any one of the following variables:\r\n* Gleason 7 disease\r\n* Prostate-specific antigen (PSA) 10-20 ng/ml\r\n* Clinical T2b-T2c disease\r\n* Note: Patients who only have radiographic evidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically) will not be excluded
Patients must have either:\r\n* A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of < 60%; please note that for the purposes of the nomogram calculation, the pre-biopsy prostate specific antigen (PSA) value must be used OR\r\n* Prostate biopsy Gleason sum >= 8 \r\n(NOTE: the Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum >= 8 only)
Low-risk prostate cancer with Gleason score <7 and prostate-specific antigen <10 mg/mL
Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA > 10, and/or Gleason score >= 7) who have a greater than 15% risk of lymph node involvement as determined by the Roach equation
Prostate biopsy must be positive for cancer: clinically localized T1c or T2a, PSA =< 10, Gleason =< 6 at the time of initial diagnosis; as the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized T1c or T2a PSA =< 10 and Gleason =< 6 for a patient who has had no treatment) will not render the patient ineligible; if the consecutive biopsy is either negative, or if positive and remains clinically localized T1c or T2a, PSA =< 10 and Gleason =< 6, the patient is eligible
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
Patients must be candidates for short or long term androgen deprivation in combination with external beam radiation therapy (RT) based on the following criteria:\r\n* Intermediate risk disease: T2b/c, or Gleason 7, or prostate-specific antigen (PSA) 10-20\r\n* High risk disease: Gleason 8-10, or PSA > 20, or T3/4
Intermediate risk prostate cancer patients will be eligible for this study; risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines; intermediate risk patients will be defined as:\r\n* PSA 10-20 ng/ml or\r\n* Gleason score = 7 or\r\n* Clinical stage T2b/T2c
prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
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)
Histologically confirmed adenocarcinoma of the prostate, clinically localized, low or low-intermediate risk disease (T1C/T2a, Gleason =< 7 [3+4], prostate-specific antigen [PSA] < 20)
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
No restrictions on stage of cancer, Gleason score, and pre-treatment prostate-specific antigen (PSA) level
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
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
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).
Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater
Intermediate to high-risk disease (as determined by elevated prostate specific antigen [PSA] [PSA > 10], tumor [T]-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
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
Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
Prostate carcinoma patients at high risk for metastasis with prostate–specific antigen (PSA) more than 20 ng/ml and/or Gleason score = 8/ > 8.
High-risk or very-high risk prostate cancer eligible for standard of care surgery\r\n* At least clinical T3a disease, and/or Gleason >= 8, and/or PSA > 20, as per clinical assessment and routine guidelines
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
Intermediate to high-risk disease (as determined by elevated PSA [PSA > 10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
Patients must have histopathology confirmed prostate cancer that is Gleason score =< 7 (4+3) clinical stage =< T2aN0M0 with a PSA below 15 ng/mL
Intermediate to high-risk disease (as determined by elevated prostate-specific antigen [PSA] [PSA > 10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
Must have previously untreated (with definitive therapy) prostate cancer with intermediate or high risk features defined as:\r\n* Intermediate risk:\r\n** Prostate specific antigen (PSA) level is between 10 and 20 ng/ml or\r\n** Gleason score is 7 or\r\n** Stage T2b or T2c\r\n* High risk:\r\n** Gleason 8 and higher OR\r\n** PSA > 20 at the time of diagnosis OR\r\n** Seminal vesicle involvement OR\r\n** Possible (on magnetic resonance [MRI]) extra-capsular extension (T3 disease)
Newly diagnosed high-risk, localized or locally advanced prostate cancer pathologically proven by prostate biopsy within the past 12 months:\r\n* Clinical T3 or greater, or\r\n* PSA > 20 ng/ml, or\r\n* Clinically N1, or\r\n* Prostate biopsy histology grade ? Gleason 8-10
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Pathologically confirmed clinically localized intermediate risk or higher prostate cancer (clinical stage >= T2b or Gleason sum >= 7 or PSA >= 10 ng/mL)
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
Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10); previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion)
National Comprehensive Cancer Network (NCCN) high risk disease (cT3 or Gleason score 8-10 or prostate specific antigen [PSA] > 20)
Candidates with prostate specific antigen (PSA) greater than 20, digital rectal exam consistent with disease outside the prostate (clinical T3/T4 disease), or Gleason score 8 or greater, should have a bone scan and diagnostic pelvic CT or MRI to exclude metastatic disease; these must be performed within 90 days of registration
Clinical criteria required to be eligible: \r\n* One of the following: \r\n** Pre-treatment prostate specific-antigen (PSA) >= 10 ng/dL, OR \r\n** Clinical T-stage assessed by digital rectal exam of >= T2a, OR\r\n** Radiographic >= T3a on MRI, OR \r\n** Gleason score of >= 3+4=7 \r\n* Visible intraprostatic tumor foci >= 1 cm in largest dimension on T2-weighted images based on initial pre-treatment MRI
INCLUSION CRITERIA:\n\n          -  Ability to provide informed consent and willingness to comply with protocol\n             requirements\n\n          -  Life expectancy ? 6 months\n\n        Cohort A only:\n\n          -  A diagnostic trans-rectal ultrasound (TRUS)-guided biopsy within 12 months of\n             enrollment showing adenocarcinoma of the prostate gland\n\n          -  Within 90 days of consent, serum PSA ? 15.0 ng/mL or ? 7.5 ng/mL if on 5 ?-reductase\n             inhibitors.\n\n          -  Candidates for active surveillance and/or a Gleason score ?3+4\n\n          -  Scheduled to undergo radical prostatectomy (RP) with or without pelvic lymph node\n             dissection (PLND)\n\n        Cohort B only:\n\n          -  Very low risk (VLR) prostate cancer defined by 2016 NCCN Guideline criteria:\n\n          -  T1c stage, and\n\n          -  PSA < 10 ng/mL, and\n\n          -  Gleason score ? 6 with < 3 biopsy cores cancer positive and ? 50% cancer in any core\n             based on prior prostate biopsy within 24 months of enrollment, and\n\n          -  PSA density < 0.15 mg/mL/g\n\n          -  Scheduled to undergo a reassessment of prostate cancer staging that includes prostate\n             biopsy as part of routine follow-up\n\n        EXCLUSION CRITERIA:\n\n          1. Subjects administered a radioisotope within 5 physical half-lives prior to study drug\n             injection.\n\n          2. Previous treatment with hormonal therapy, surgery (except biopsy), radiation therapy,\n             LHRH analogs, and non-steroidal anti-androgens, for the treatment of prostate cancer\n             or benign prostatic hyperplasia (BPH)\n\n          3. Planned androgen or anti-androgen therapy prior to RP surgery or biopsy\n\n          4. Subjects with any medical condition or other circumstances that, in the opinion of the\n             investigator, would significantly interfere with obtaining reliable data, achieving\n             study objectives, or completing the study\n\n          5. Malignancy (not including curatively treated basal or squamous cell carcinoma of the\n             skin) within the previous 5 years. (Ta stage transitional cell carcinoma bladder\n             cancer with negative surveillance cystoscopy within the past 2 years may be included).
Patients with clinically localized adenocarcinoma of the prostate who are scheduled to undergo radical prostatectomy (RP) with curative intent and have any the following clinico-pathologic features: (1) Gleason score sum >= 4+3 or any Gleason 5, (2) PSA > 20, and/or (3) clinical stage >= T3a (staging by magnetic resonance imaging [MRI] is allowed)
At least 2 of the following 3 factors: Gleason score(GS) 3+4=7 and/or PSA 10-20 and/or T2b/c
Greater than 50% of biopsy cores positive and at least one other risk factor: Gleason score (GS) 7 and/or PSA 10-20 and/or T2b/c