Radiation and Androgen Ablation for Prostate Cancer

This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined
regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5
fractions) with androgen deprivation therapy (ADT) for 4 months total.

Inclusion Criteria:

- Histologically confirmed, locally confined adenocarcinoma of the prostate

- Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA
(prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).

- The patient has decided to undergo external beam radiation as treatment choice for his
prostate cancer.

- Signed study-specific consent form prior to registration

Exclusion Criteria:

- Stage T3-4 disease.

- Gleason 8 or higher score.

- PSA > 20 ng/ml.

- IPSS (International Prostate Symptom Score) > 15

- Clinical or Pathological Lymph node involvement (N1).

- Evidence of distant metastases (M1).

- Radical surgery for carcinoma of the prostate.

- Previous Chemotherapy, unless intervention was greater than 5 years from beginning
treatment for current prostate cancer.

- Previous pelvic radiation therapy.

- Previous or concurrent cancers other than basal or squamous cell skin cancers or
superficial bladder cancer unless disease free for at least 5 years.

- History of inflammatory bowel disease.

- Major medical or psychiatric illness which, in the investigator's opinion, would
prevent completion of treatment and would interfere with follow up.

- Myocardial infarction or cerebrovascular accident within one year from consultation,
or other major vascular risk factor which would prevent a patient from receiving
appropriate androgen deprivation therapy.11

- Liver function tests (LFTs) greater than twice the upper limit of normal.