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

This study is ongoing, but not recruiting participants.
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: October 20, 2015
Last verified: October 2015

December 20, 2007
October 20, 2015
April 2007
August 2015   (final data collection date for primary outcome measure)
Toxicity to the rectum within the first two years of radiation treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
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 day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.
Interventional
Phase 2
Allocation: Non-Randomized
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 lovaststin. 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: Brachytherapy & Lovastatin for 1 yr
    Subject begins taking lovastatin on the evening after their radiation implant. They should continue taking 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 each visit they will have their vital signs checked, will be asked about their health since last visit, and will have blood drawn to check their PSA and they will complete the 2 questionnaires. 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
  • Experimental: Radiation Therapy & Lovastatin for 1 yr
    Subject begins taking lovastatin on evening after their first radiation treatment. Continues taking lovastatin once per day for 1 year. The number of radiation therapy treatments will be determined by their radiation oncologist. During radiation therapy, they are checked once per week by radiation oncologist. During this weekly check up, they are asked about side effects, vital signs checked and may have blood drawn. They will fill out the 2 questionnaires again. After radiation treatments, 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 radiation. At each visit vital signs checked,ask about health since their last visit, have blood drawn to check PSA and will complete the 2 questionnaires. At 8 weeks, 4 months, 6 months, 9 months and 12 months, they will also have a blood test to check their liver.
    Intervention: Drug: lovastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
53
November 2016
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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580970
MCC-10802
Yes
Not Provided
Not Provided
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
October 2015

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