A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate

- Planned treatment with radiation therapy to include external beam and/or
brachytherapy with curative intent (total dose ≥60 Gy). A portion of the rectum must
receive at least 60 Gy.

- Age at least 18 years

- Karnofsky Performance Status (KPS) ≥ 70

- No history of prior radiotherapy to the prostate or rectum

- History of prior malignancy, if likely to live at least 4 years, is acceptable.

- No evidence of distant metastases

- Patients may be taking an HMG-coA-reductase inhibitor, but to be eligible, they must
be able to be changed to lovastatin 20 mg/day, with the permission of their
prescribing physician.

- Creatine kinase < 5 times upper normal limit

- Sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min

- transaminases < 3 times upper normal limit

Exclusion Criteria:

- Planned abdomino-perineal resection after radiotherapy

- Contraindication to an HMG-coA-reductase inhibitor

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

- Currently taking an inhibitor of cytochrome P450 3A4

- Active liver or muscle disease