High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)

In this study the treating physicians will deliver a high dose of radiation to pelvic lymph
nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost
(additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the
response of the cancer and side effects of radiation to pelvic lymph nodes and to the
prostate.

It is hoped that these newer technologies will:

1. allow a higher daily dose of radiation to the tumor and pelvic nodes

2. avoid nearby normal tissue and organs like the rectum and bladder

3. prevent the cancer from spreading or coming back

Inclusion Criteria:

- Histologically confirmed, adenocarcinoma of the prostate

- T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA)
+ (Gleason Score - 6)x10], or any T3-4N0M0

- Karnofsky Performance Scale > 70 (Appendix II).

- Prostate tumor biopsy grading by Gleason score classification is mandatory prior to
registration (Appendix V).

- No prior pelvic or prostate radiation or chemotherapy for any reason; induction
hormonal therapy prior to registration is acceptable.

- Patients must sign a study-specific consent form prior to registration.

- No evidence of distant metastases (Bone scanning)

Exclusion Criteria:

- Clinical or pathological evidence of distant metastases (M1).

- Radical surgery for carcinoma of the prostate

- History of prior chemotherapy

- History of prior pelvic radiation therapy

- Children (age < 18).