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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: lovastatin

• Registration Number: NCT00580970
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-27
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2016-06-03
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-28
• Last Update Submitted: 2016-09-28
• Results First Posted: 2016-11-18
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 73

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lovastatin for 1 yr	lovastatin	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment	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.

Trial Locations

Locations (3)

Hunter Holmes McGuire Veterans Administration Medical Center; 🇺🇸 Richmond, Virginia, United States

Massey Cancer Center/Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Southside Regional Medical Center; 🇺🇸 Richmond, Virginia, United States