A Phase I Dose-Escalation Study of Preoperative Radiation Therapy Followed by Radical Prostatectomy in Patients With High Risk, Localized Carcinoma of the Prostate

Inclusion Criteria:

Subjects must have

- biopsy-confirmed "high-risk" prostate cancer, defined as A. PSA > 20, B. Gleason
Score (GS) >/= 8, and/or C. Clinical stage T3 disease per AJCC Staging Manual, 6th
edition; or D. At least two out of three of the following: PSA 10-19.9, GS = 7, or
clinical stage = T2b / T2c.

- a negative bone scan,

- be medically fit to undergo surgery as determined by treating urologist,

- under 70 years of age,

- KPS must be >/= 80,

- no prior pelvic radiation therapy, chemotherapy, or androgen deprivation,

- no prior invasive malignancy, except non- melanomatous skin cancer unless disease
free for a minimum of 5 years. Carcinoma in-situ of the bladder or head and neck
region is permissible.

- Subjects must freely sign informed consent to enroll in the study.

Exclusion Criteria:

- prior pelvic radiation therapy, chemotherapy, or androgen deprivation,

- prior invasive malignancy, except non- melanomatous skin cancer, carcinoma in-situ of
the bladder or head and neck region, unless disease free for a minimum of 5 years.