Androgen Deprivation Therapy and SBRT versus SBRT Alone for the Treatment of Unfavorable Intermediate Risk Prostate Cancer

Inclusion Criteria

• 18 years of age or older male participants
• Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: * Gleason 4+3 disease * Percent positive cores ≥ 50% including at least one of Gleason 7 core * 2-3 intermediate risk factors ** Gleason 7 ** PSA 10-20 ng/mL ** T2b-T2c (T2b: the tumor has spread to more than one-half of one side of the prostate, but not to both sides. T2c: the cancer has invaded both sides of the prostate) Note: Patients who have radiographic evidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically which is considered probable or suspicious) will be excluded
• Patients must have tissue available for Decipher score testing. Results must be available before start of radiation treatment. * Note: If a patient already has a Decipher score available, it can be used for eligibility
• Serum testosterone ≥ 150 ng/dL determined prior to ADT start
• At least 4 weeks must have elapsed from major surgery
• Karnofsky Performance Scale (KPS) ≥ 80%
• Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined on CT scan if MRI is not available
• IPSS ≤ 20
• Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy if indicated under physician discretion, telephone and chart review-based follow-up will be acceptable
• Serum bilirubin ≤ 1.5 times the upper institutional limits of normal (ULN) (within 8 weeks of start of radiation treatment) Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 8 weeks of start of radiation treatment)
• Serum creatinine ≤ 1.5 x ULN (within 8 weeks of start of radiation treatment)
• Absolute neutrophil counts ≥ 1,500 cell/mm^3 (within 8 weeks of start of radiation treatment)
• Platelets ≥ 100,000 cells/mm^3 (within 8 weeks of start of radiation treatment)
• Hemoglobin value ≥ 9 g/dL (within 8 weeks of start of radiation treatment) (Note: patients whose anemia has been corrected to a hemoglobin value ≥ 9 g/dL with blood transfusions are allowed)

Exclusion Criteria

• CT or MRI or positron emission tomography (PET) scan evidence of metastatic disease to the bone
• Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
• Prior history of chemotherapy or surgery for prostate cancer (except for prior [transurethral resection of prostate] TURP or greenlight [photoselective vaporization of prostate] PVP which would be allowed) * Note: Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is ≤ 60 days prior to registration. These patients will be registered into separate stratum within each primary treatment cohort
• History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years
• Patients with Crohn’s disease or ulcerative colitis