Back to resultsStudy of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lovastatin
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate cancer, radiation therapy, lovastatin, rectal injury
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
Sites / Locations
- Hunter Holmes McGuire Veterans Administration Medical Center
- Massey Cancer Center/Virginia Commonwealth University
- Southside Regional Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lovastatin for 1 yr
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00580970
First Posted
December 20, 2007
Last Updated
September 28, 2016
Sponsor
Virginia Commonwealth University
Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00580970
Brief Title
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
Official Title
A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, radiation therapy, lovastatin, rectal injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lovastatin for 1 yr
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lovastatin
Other Intervention Name(s)
Altoprev, Mevacor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
Description
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.
Time Frame
24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S. Anscher, MD
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire Veterans Administration Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Massey Cancer Center/Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Southside Regional Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23805
Country
United States
12. IPD Sharing Statement
Links:
URL
http://meetinglibrary.asco.org/content/158568-172
Description
2016 Genitourinary Cancers Symposium
Learn more about this trial
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
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