Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Virginia Commonwealth University
With
Hunter Holmes Mcguire Veteran Affairs Medical Center
Oral lovastatin will be given at the dose of 20 mg/day with evening meal beginning on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the first day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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
