Impact of Atorvastatin on Prostate Cancer Progression During ADT

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Male

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 (ADT) for prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampere University Hospital
• Collaborators: Central Finland Hospital District; Fimlab laboratories; Helsinki University Central Hospital; Kuopio University Hospital; Tartu University Hospital; Turku University Hospital; University of Aarhus
• Treatments: Atorvastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).