Radiation Therapy with or without Androgen-Deprivation Therapy in Treating Patients with Prostate Cancer

Inclusion Criteria

• 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: * Gleason score 7 * Prostate specific antigen (PSA) > 10 but =< 20 * Clinical stage T2b-T2c * 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
• Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal computed tomography [CT] scan or magnetic resonance imaging [MRI]), nodal sampling, or dissection within 60 days prior to registration, except as noted immediately below: * Patients with a single intermediate risk factor only do not require abdominopelvic imaging, but these studies may be obtained at the discretion of the treating physician; patients with 2 or 3 risk factors are required to undergo pelvic +/- abdominal CT or MRI * Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are =< 1.5 cm; any node larger than this on imaging will require negative biopsy for eligibility
• No evidence of bone metastases (M0) on bone scan within the past 60 days prior to registration * Bone scan not required for patients enrolled with a single intermediate-risk factor only but this scan may be obtained at the discretion of the treating physician; patients with 2 or 3 risk factors will require a negative bone scan for eligibility * Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis
• History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration; Note: the ACE-27 is posted on the 0815 protocol information page on the NRG Oncology/Radiation Therapy Oncology Group (RTOG) web site
• Zubrod performance status 0-1
• Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration * Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT; (3) within 30 days after discontinuation of finasteride; or (4) within 90 days after discontinuation of dutasteride
• For patients undergoing brachytherapy only: complete blood count (CBC)/differential obtained within 60 days prior to registration, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) >= 1,800 cells/mm^3
• Platelet count >= 100,000 cells/mm^3
• Hemoglobin >= 8.0 g/dL (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8 g/dl is acceptable)
• Patient must be able to provide study-specific informed consent prior to study entry

Exclusion Criteria

• Patients with Gleason score >= 8; PSA > 20; OR clinical stage >= T3 are ineligible for this trial * Should findings of extracapsular extension or seminal vesicle invasion be noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol; primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement
• Patients with all three intermediate risk factors who also have >= 50% of the number of their biopsy cores positive for cancer are ineligible for this trial
• Prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted)
• Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
• Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol [DES]), or bilateral orchiectomy
• Use of finasteride within 30 days prior to registration
• Use of dutasteride within 90 days prior to registration
• Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
• Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields * Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) score =< 15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP); prior TURP is permitted for patients who receive EBRT only
• Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; while the treatment employed in this study is not significantly immunosuppressive, it is felt that a diagnosis of AIDS associated with prostate cancer is likely to impact this study’s primary endpoint of overall survival; patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation
• Men who are sexually active with a woman of child-bearing potential and not willing/able to use medically acceptable forms of contraception (e.g., surgical, barrier, medicinal) during protocol treatment and during the first 3 months after cessation of protocol treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic