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

Prostate Cancer Clinical Trial

Official title:

A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580970
• Other study ID #: MCC-10802
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: February 25, 2016
• Start date: April 2007
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• lovastatin
The HMG-coA reductase inhibitor used in this study will be lovaststin. Dosage: 20 mg/d PO with evening meal. Patients on a higher dose of lovastatin at the time of study entry may continue at that dose level; for patients switching to lovastatin, the dose will be at the discretion of the prescribing physician, but must be at least 20 mg/day.Schedule: begin 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. Patients or their third party payers will be expected to cover the cost of the drug.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity to the rectum within the first two years of radiation treatment		24 months	Yes