Clinical trial · Interventional
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin
NCT00580970CI-TRIAL-00024837completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lovastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lovastatin for 1 yr
- 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.
- interventionNames
- Drug: lovastatin
Primary outcomes (1)
- measure
- Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
- timeFrame
- 24 months
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.