ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

Inclusion Criteria:

• Biopsy proven unfavorable intermediate risk prostate cancer, which includes patientswith any one of the following variables: Gleason 4+3 disease; Percent positive cores > 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20ng/mL; or T2b-T2c)

• Patients must have tissue available for Decipher score testing. Results must beavailable before start of treatment.

• Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment

• 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 onCT scan if MRI is not available

• IPSS ≤ 20

• Patient must be available for follow-up. After 2 years of follow-up, upon completionof post-treatment biopsy, telephone and chart review-based follow-up will beacceptable

• Adequate hepatic function with serum bilirubin less than or equal to 1.5 times theupper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) andAspartate Aminotransferase (AST) less than or equal to 2.5 x ULN. Patients with ahistory of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dLwith a predominance of indirect bilirubin

• Adequate renal function with serum creatinine less than or equal to 1.5 x ULN

• Adequate hematologic function with absolute neutrophil counts of at least 1,500cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value > 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value > 9 g/dL withblood transfusions are allowed).

Exclusion Criteria:

• CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic diseaseto the bone

• Patients with one or more positive lymph nodes considered suspicious as determinedby clinical assessment on MRI or CT or PET scan

• Prior treatment for prostate cancer, including history of chemotherapy, hormonaltherapy within 30 days of enrollment or surgery for prostate cancer (except forprior (transurethral resection of prostate) TURP or greenlight (photoselectivevaporization of prostate) PVP which would be allowed)

• History of another malignancy within the previous 2 years except for the following:adequately treated basal cell or squamous cell skin cancer, superficial bladdercancer, currently in complete remission, or any other cancer that has been incomplete remission for at least 3 years

• Patients with Crohn's disease or ulcerative colitis