Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Inclusion Criteria:

• Pathologically (histologically or cytologically) proven diagnosis of prostaticadenocarcinoma within 180 days of registration at moderate- to high-risk forrecurrence as determined by one of the following combinations:

• Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50ng/mL (includes intermediate- and high-risk patients)

• Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml

• Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL

• Patients previously diagnosed with low risk prostate cancer undergoing activesurveillance who are re-biopsied and found to have unfavorable intermediate riskdisease or favorable high risk disease according to the protocol criteria areeligible for enrollment within 180 days of the repeat biopsy procedure

• History/physical examination (to include at a minimum digital rectal examination ofthe prostate and examination of the skeletal system and abdomen) within 90 days priorto registration

• Clinically negative lymph nodes as established by imaging (pelvic and/or abdominalcomputed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, ordissection) within 90 days prior to registration

• Patients with lymph nodes equivocal or questionable by imaging are eligible ifthe nodes are =< 1.5 cm

• No evidence of bone metastases (M0) on bone scan within 120 days prior toregistration (sodium fluoride [NaF] positron emission tomography [PET]/CT is anacceptable substitute)

• Equivocal bone scan findings are allowed if plain films (or CT or magneticresonance imaging [MRI]) are negative for metastasis

• Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approvedassay (e.g., Abbott, Hybritech) within 120 days prior to registration

• Study entry PSA should not be obtained during the following time frames:

• 10-day period following prostate biopsy

• Following initiation of hormonal therapy

• Within 30 days after discontinuation of finasteride

• Within 90 days after discontinuation of dutasteride

• Zubrod performance status 0-1 (unless otherwise specified)

• Absolute neutrophil count (ANC) >= 1,500/mm³

• Platelets >= 100,000/mm³

• Hemoglobin (Hgb) >= 8.0 g/dL (Note: the use of transfusion or other intervention toachieve Hgb >= 8.0 g/dL is acceptable)

• Patient must be able to provide study specific informed consent prior to study entry

Exclusion Criteria:

• Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for aminimum of 3 years (1095 days) not in the pelvis (for example, carcinoma in situ ofthe oral cavity is permissible; however, patients with prior history of bladdercancer are not allowed); prior hematological (e.g., leukemia, lymphoma, myeloma)malignancy not allowed

• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

• Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

• Previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin,buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g.,flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)

• Prior pharmacologic androgen ablation for prostate cancer is allowed only if theonset of androgen ablation (both LHRH agonist and oral anti-androgen) is =< 45 daysprior to the date of registration

• Use of finasteride within 30 days prior to registration

• Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior toregistration

• Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that priorchemotherapy for a different cancer is allowable

• Prior radiotherapy, including brachytherapy, to the region of the study cancer thatwould result in overlap of radiation therapy fields

• Severe, active co-morbidity, defined as follows:

• Unstable angina and/or congestive heart failure requiring hospitalization withinthe last 6 months

• Transmural myocardial infarction within the last 6 months

• Acute bacterial or fungal infection requiring intravenous antibiotics at thetime of registration

• Chronic obstructive pulmonary disease exacerbation or other respiratory illnessrequiring hospitalization or precluding study therapy at the time ofregistration

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defectsor severe liver dysfunction

• Acquired immune deficiency syndrome (AIDS) based upon current Centers forDisease Control and Prevention (CDC) definition; note, however, that humanimmunodeficiency virus (HIV) testing is not required for entry into thisprotocol; protocol-specific requirements may also exclude immuno-compromisedpatients

• Patients who are sexually active and not willing/able to use medically acceptableforms of contraception

• Prior allergic reaction to the hormones involved in this protocol

• Patients status post a negative lymph node dissection are not eligible