Clinical trial · Interventional
Cellular Effect of Cholesterol-Lowering Prior to Prostate Removal
Phase 0 Trial of Presurgical Cholesterol-lowering on Prostate Cancer Cell Growth
- 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)
There is evidence in human studies as well as animal studies that treatments to lower cholesterol can reduce the risk of dying from prostate cancer.To decide if cholesterol-lowering therapy can slow the growth of prostate cancer, the investigators would like to lower cholesterol prior to surgery and then measure the growth of prostate cancers cells when the prostate has been removed. The investigators will use the combination of two drugs that is approved by the U.S. Food and Drug Administration to lower cholesterol. The drug combination is commercially available with a doctor's prescription and sold as Vytorin®. It is known that maximal cholesterol-lower effects are seen after 2 weeks of treatment with Vytorin®. Therefore, study patients receive at least 2 weeks, but no more than 6 weeks of Vytorin® prior to surgery.
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 |
|---|---|---|---|
| ezetimibe 10mg-simvastatin 40mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Vytorin (ezetimibe 10mg-simvastatin 40mg)
- interventionNames
- Drug: ezetimibe 10mg-simvastatin 40mg
Primary outcomes (1)
- measure
- Growth of Gleason grade 3 prostate cancer
- timeFrame
- following 2-6 weeks of cholesterol lowering intervention.
- description
- Prostate tissue removed at the time of surgery will be examined to measure cellular growth using molecular assays.
Secondary outcomes (2)
- measure
- Growth of benign prostate glands
- timeFrame
- following 2-6 weeks of cholesterol lowering intervention.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy containing ≥ 10 tissue cores sampled * Biopsy positive for adenocarcinoma of the prostate containing any quantity of Gleason 3 component (e.g. Gleason score 3+3, 3+4, 4+3) * Scheduled to undergo robotic radical prostatectomy * Serum Prostate-Specific Antigen (PSA) \<20 ng/ml * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Pharmacologic therapy (e.g. statins or ezetimibe) to lower cholesterol within 30 days prior to registration. * Prior treatment for CaP by surgery, irradiation, local ablative (e.g. cryosurgery or high intensity focused ultrasound) or androgen deprivation therapy. * 5-alpha reductase inhibitors (e.g. finasteride or dutasteride) within 180 days prior to registration. * Hypersensitivity to simvastatin or ezetimibe. * Pharmacologic therapy with agents reported to produce adverse drug-drug interactions. (Table 2)
References
Publications (0)
Data not yet available