Overview
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
Status:
Completed
Completed
Trial end date:
2015-08-01
2015-08-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
Lovastatin may protect against late effects of radiation therapy in patients with prostate cancerPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Virginia Commonwealth UniversityCollaborator:
Hunter Holmes Mcguire Veteran Affairs Medical CenterTreatments:
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