Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
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|ClinicalTrials.gov Identifier: NCT00580970|
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : November 18, 2016
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: lovastatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin|
|Study Start Date :||April 2007|
|Primary Completion Date :||August 2015|
|Study Completion Date :||August 2015|
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.
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.
- Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment [ Time Frame: 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580970
|United States, Virginia|
|Hunter Holmes McGuire Veterans Administration Medical Center|
|Richmond, Virginia, United States, 23249|
|Massey Cancer Center/Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Southside Regional Medical Center|
|Richmond, Virginia, United States, 23805|
|Principal Investigator:||Mitchell S. Anscher, MD||Massey Cancer Center|