Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Inclusion Criteria:

• Biopsy proven intermediate risk prostate cancer, which includes patients with anyone of the following variables:

• Gleason 7 disease

• PSA 10-20 ng/ml

• Clinical T2b-T2c disease Note: Patients who only have radiographic evidence of T3disease (i.e. extracapsular extension, or seminal vesical invasion radiographically)will not be excluded.

• Serum testosterone ≥ 240 ng/dL determined within 2 months prior to enrollment

• At least 4 weeks must have elapsed from major surgery

• KPS ≥ 80%

• Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined onCT scan if MRI is not available.

• 18 years of age or older

• IPSS ≤ 20

• Patient must be available for follow-up. After 2 years of follow-up followingpost-treatment biopsy, telephone-based follow-up will be acceptable

• Laboratory test findings within 8 weeks of randomization:

• Adequate hepatic function with serum bilirubin ≤ 1.5 times the upperinstitutional limits of normal (ULN), ALT and AST ≤ 2.5 x ULN. Patients with ahistory of Gilbert's syndrome may be enrolled if the total bilirubin is < 3mg/dL with a predominance of indirect bilirubin

• Adequate renal function with serum creatinine ≤ 1.5 x ULN

• Adequate hematologic function with absolute neutrophil counts ≥ 1,500 cell/mm3and platelets ≥ 100,000 cells/mm3 and hemoglobin value ≥ 9 g/dL (Note: patientswhose anemia has been corrected to a hemoglobin value ≥ 9 g/dL with bloodtransfusions are allowed)

Exclusion Criteria:

• CT or MRI evidence of metastatic disease to the bone.

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

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

• History of another malignancy within the previous 3 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