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

DISEASE CHARACTERISTICS:

• 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:

  • Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)
  • Gleason score 6 + T2c-T4 (palpation) or > 50% (positive) biopsies + PSA < 50 ng/mL
  • Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL
• History and/or physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration

• Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration

  • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm
  • Patients status post a negative lymph node dissection are not eligible

• No evidence of bone metastases (M0) on bone scan within 120 days prior to registration

  • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis
• Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration

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

  • Ten-day period following prostate biopsy
  • Following initiation of hormonal therapy
  • Within 30 days after discontinuation of finasteride
  • Within 90 days after discontinuation of dutasteride

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)

• No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1,095 days) and not in the pelvis

  • E.g., carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed
  • No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy

• No severe, active co-morbidity, defined as any of the following:

  • 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 at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction

  • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition

    • Protocol-specific requirements may also exclude immuno-compromised patients
    • HIV testing is not required for entry into this protocol
• No patients who are sexually active and not willing/able to use medically acceptable forms of contraception
• No prior allergic reaction to the hormones involved in this protocol

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
• No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
• No prior hormonal therapy, such as luteinizing hormone-releasing hormone (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)
• No prior pharmacologic androgen ablation for prostate cancer unless the onset of androgen ablation is ≤ 45 days prior to the date of registration
• No finasteride within 30 days prior to registration
• No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

• No prior or concurrent cytotoxic chemotherapy for prostate cancer

  • Prior chemotherapy for a different cancer is allowable
• No prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields