Clinical trial · Interventional
Statin Therapy Versus Placebo Prior to Prostatectomy
Pre-Operative Statin Therapy Versus Placebo in Human Prostate Cancer
NCT00572468CI-TRIAL-00028610completedN/AResults 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)
This is a randomized trial comparing the effect of oral simvastatin versus placebo on targets of the mevalonate pathway in men undergoing a prostatectomy as planned management for prostate cancer. Observed tissue effects will be correlated with changes in serum cholesterol and low-density lipoprotein.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Simvastatin
- description
- Twenty-two men will be on the Statin arm and take 40 mg of simvastatin.
- interventionNames
- Drug: Simvastatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Twenty-two men will be on the placebo arm.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostatic adenocarcinoma with Gleason 5 to 7 (3+4 = 7 accepted, not 4 + 3 = 7) * Radical prostatectomy chosen as primary treatment for prostate cancer * Age 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Other preoperative or prior treatment directed at prostate cancer (i.e., Radiation, hormonal therapy, cryotherapy) * Significant active medical illness which in the opinion of the investigator would preclude protocol treatment * History of or active liver disease or abnormal results of the baseline liver function test (\> 2 x normal) * Current use of: * simvastatin * lovastatin * other HMG-CoA inhibitors * lipid-lowering agents * Amiodarone * Cholestyramine * Cholestyramine and colestipol (bile acid sequestrants) * Clofibrate and fenofibrate * Cyclosporine * CYP3A4 inhibitors * Danazol * Diltiazem * Gemfibrozil * Niacin ( 1 g/day) * Verapamil and Warfarin * Known allergy or sensitivity to ingredients in simvastatin
References
Publications (0)
Data not yet available
No reference posted for this study.