Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer
Key facts
- Study ID
- NCT00580970
- Run by
- Virginia Commonwealth University
- People needed
- 73
- Starts
- 2007-04-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2016-11-18
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hunter Holmes McGuire Veterans Administration Medical Center — Richmond, Virginia, United States
- Massey Cancer Center/Virginia Commonwealth University — Richmond, Virginia, United States
- Southside Regional Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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