Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Treatments: Dihydromevinolin; L 647318; Lovastatin

Criteria

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