- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00580970
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
September 28, 2016 updated by: Virginia Commonwealth University
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 Overview
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.
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Richmond, Virginia, United States, 23249
- Hunter Holmes McGuire Veterans Administration Medical Center
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Richmond, Virginia, United States, 23298
- Massey Cancer Center/Virginia Commonwealth University
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Richmond, Virginia, United States, 23805
- Southside Regional Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
Time Frame: 24 months
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The primary endpoint of this study was percentage of participants with physician reported rectal toxicity ≥Grade 2 during the first 2 years after treatment.
A one sided test will be conducted in order to evaluate reduction of risk from adding Lovastatin.
The analysis is using a one-stage design, 5% level of significance, and 83% power.
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mitchell S. Anscher, MD, Massey Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 20, 2007
First Posted (Estimate)
December 27, 2007
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
September 28, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Lovastatin
- L 647318
- Dihydromevinolin
Other Study ID Numbers
- MCC-10802
- NCI-2011-01676 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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