Clinical trial · Interventional
Atorvastatin Before Prostatectomy and Prostate Cancer
The Impact of Atorvastatin on Prostate Cancer - a Randomized, Pre-surgical Clinical Trial
NCT01821404CI-TRIAL-00032803ESTO1completedPhase 2ClinicalTrials.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 single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Similar capsules as in the atorvastatin arm, but including no active ingredient. Used daily for 3-5 weeks before prostatectomy
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Atorvastatin
- description
- Atorvastatin capsules orally, 80 mg daily for 3-5 weeks before prostatectomy
- interventionNames
- Drug: Atorvastatin
Primary outcomes (4)
- measure
- Apoptosis
- timeFrame
- Four weeks after recruitment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer proven histologically in prostate biopsy * Radical prostatectomy selected as the first-line treatment * Willingness to participate and sign informed consent Exclusion Criteria: * Previous oncological treatments for any malignancy * Previous usage of statins, finasteride or dutasteride within a year prior to prostate cancer diagnosis * Clinically significant liver- or kidney insufficiency (plasma alanine aminotransferase level is twice over the recommended upper limit or serum creatinine level is over 170 µmol/l) * Previous adverse effects from cholesterol-lowering treatment * Ongoing use of drugs having interactions with statins (St John's Wort, HIV protease inhibitors, ciclosporin, macrolide antibiotics, fusidic acid, phenytoin, carbamazepine, dronedarone or oral antifungal medication)
References
Publications (1)
- DERIVEDRaittinen PVH, Syvala H, Tammela TLJ, Hakkinen MR, Ilmonen P, Auriola S, Murtola TJ. Atorvastatin induces adrenal androgen downshift in men with prostate cancer: A post Hoc analysis of a pilot adaptive Randomised clinical trial. EBioMedicine. 2021 Jun;68:103432. doi: 10.1016/j.ebiom.2021.103432. Epub 2021 Jun 16. PMID 34144486