PreOperative RadioTherapy for High-Risk Prostate Cancer (PORT-PC Trial)

Patients with a diagnosis of high risk prostate cancer with a Gleason score of 8 or greater
are eligible for this trial. The study will enroll 20 subjects in 3 years. This is a single
arm study and the primary objectives is to assess if a patient can undergo a radical
prostatectomy after SBRT without a post-operative gastrointestinal or urinary grade 4 or 5
toxicity at 30 days. Secondary objectives are to assess acute toxicity and quality of life
scores. Exploratory objectives will include analysis of tumor and normal biopsied and
resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.

Inclusion Criteria:

- Men aged greater than equal to18 with histologically confirmed primary prostate
cancer.

- KPS greater than equal to 70

- Patient with a negative staging bone scan.

- Patient can undergo an MRI.

- Patient willing to undergo placement of a rectal spacer.

- Patient with negative staging CT or MRI of pelvis. Suspicious evidence of nodal
involvement on staging CT or MRI of pelvis is defined as greater than 1 cm on short
axis. Documented negative biopsy of suspicious node required.

- Patient is medically fit to undergo prostatectomy.

- Patient has either Gleason Score greater than equal to 8 on biopsy and/or
clinical/radiographic evidence of T3 disease.

Exclusion Criteria:

- Prior history of receiving androgen deprivation therapy.

- Prior history of receiving chemotherapy.

- Prior history of receiving pelvic radiotherapy.

- Patient is unwilling to undergo prostatectomy.

- Patient with active inflammatory bowel disease defined as currently receiving therapy
for IBD.