Official Title: “A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin”

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

Study Type: Interventional

Study Design: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: October 2008

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 day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.

Intervention(s) in this Clinical Trial

• Drug: lovastatin
  • 20 mg/day for 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Lovastatin + radiation therapy

Primary Measures

• Toxicity to the rectum toxicity within the first two years of radiation treatment
  • Time Frame: 18 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Virginia Commonwealth University

Overall Clinical Trial Officials and Contacts

Mitchell S. Anscher, MD Principal Investigator Massey Cancer Center  

Overall Contact: Mitchell S. Anscher, MD 804-828-7238 msanscher@vcu.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580970

Study ID Number: MCC-10802

ClinicalTrials.gov Identifier: NCT00580970

Health Authority: United States: Institutional Review Board

Massey Cancer Center Clinical Trials