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

NCT ID: NCT00580970

Last Updated: 2016-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2015-08-31

Brief Summary

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

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

Conditions

Prostate Cancer

Keywords

prostate cancer; radiation therapy; lovastatin; rectal injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lovastatin for 1 yr

Lovastatin (20-80 mg/d) was started on day 1 of radiation and continued for 12 months. Patients were followed for an additional 12 months. Lovastatin once per day for 1 year. After the implant, they are asked to return for checkups (study visits 4-13) 4 weeks, 8 weeks, 4 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months after the procedure. At 8 weeks, 4 months, 6 months, 9 months and 12 months, will also have a blood test to check their liver.

Group Type: EXPERIMENTAL

lovastatin

Intervention Type: DRUG

The HMG-coA reductase inhibitor used in this study will be lovastatin. 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.

Interventions

lovastatin

The HMG-coA reductase inhibitor used in this study will be lovastatin. 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.

Intervention Type: DRUG

Other Intervention Names

Altoprev; Mevacor

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell S. Anscher, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

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

Countries

United States

Related Links

http://meetinglibrary.asco.org/content/158568-172

2016 Genitourinary Cancers Symposium

Other Identifiers

NCI-2011-01676

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-10802

Identifier Type: -

Identifier Source: org_study_id