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

This study has been completed.
Sponsor:
Collaborator:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00580970
First received: December 20, 2007
Last updated: September 28, 2016
Last verified: September 2016

December 20, 2007
September 28, 2016
April 2007
August 2015   (final data collection date for primary outcome measure)
Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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.
Toxicity to the rectum toxicity within the first two years of radiation treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00580970 on ClinicalTrials.gov Archive Site
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Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
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
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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Prostate Cancer
Drug: 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.
Other Names:
  • Altoprev
  • Mevacor
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.
Intervention: Drug: lovastatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580970
MCC-10802, NCI-2011-01676
Yes
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Virginia Commonwealth University
Virginia Commonwealth University
Hunter Holmes Mcguire Veteran Affairs Medical Center
Principal Investigator: Mitchell S. Anscher, MD Massey Cancer Center
Virginia Commonwealth University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP