Status:
UNKNOWN
Impact of Atorvastatin on Prostate Cancer Progression During ADT
Lead Sponsor:
Tampere University Hospital
Collaborating Sponsors:
Turku University Hospital
Central Finland Hospital District
Conditions:
Metastatic Prostate Cancer
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This randomized double-blind placebo-controlled trial tests whether intervention with atorvastatin delays development of castration resistance compared to placebo during androgen deprivation therapy (...
Detailed Description
Cholesterol-lowering statin drugs have been reported to lower proliferation activity in prostate cancer, delay occurrence of castration resistance and reduce the risk of prostate cancer death. Therefo...
Eligibility Criteria
Inclusion
- Histopathologically confirmed metastatic (radiologically confirmed bone or soft tissue metastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelvic lymph nodes) or recurrent (requiring treatment after curative-intent surgery or radiotherapy) adenocarcinoma of the prostate for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated as definitive treatment no longer than 3 months before recruitment
- previous prostatectomy and radiation therapy allowed
- ADT/antiandrogen therapy for neoadjuvant hormone therapy is not included
- Willingness to participate and signing of informed consent
Exclusion
- Statin use at the time of recruitment or within 6 months of it
- Previous adverse effects during statin therapy
- Familial hypercholesterolemia or very high total cholesterol (9.3 mmol/l or above)
- Clinically significant renal insufficiency (serum creatinine above 170 µmol/l) or liver insufficiency (serum alanine aminotransferase more than 2x above the upper limit of normal range)
- Use of drugs that may interact with statins (St John's Wort, HIV protease inhibitors, ciclosporin, macrolide antibiotics, fucidic acid, phenytoin, carbamazepine, dronedarone or oral antifungal medication).
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04026230
Start Date
August 15 2019
End Date
December 31 2025
Last Update
October 21 2022
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Herlev and Gentofte Hospital
Herlev, Denmark
2
Tartu University Hospital
Tartu, Estonia
3
Helsinki University Hospital, Department of Urology
Helsinki, Finland
4
Central Finland central hospital
Jyväskylä, Finland