Impact of Atorvastatin on Prostate Cancer Progression During ADT (ESTO2)
Metastatic Prostate Cancer, Recurrent Prostate Cancer
About this trial
This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring Prostate cancer, Castration resistance, Cholesterol lowering drug, Cholesterol, Atorvastatin, Survival, Mortality
Eligibility 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).
Sites / Locations
- Herlev and Gentofte Hospital
- Tartu University HospitalRecruiting
- Helsinki University Hospital, Department of UrologyRecruiting
- Central Finland central hospitalRecruiting
- Kuopio University Hospital, Department of Urology
- Seinäjoki Central Hospital, Department of SurgeryRecruiting
- Tampere University HospitalRecruiting
- Turku University HospitalRecruiting
- The Hospital of TelemarkRecruiting
- The Hospital of VestfoldRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Atorvastatin
Placebo
Capsules of atorvastatin. Daily dose of 80 mg for max. 10 years or until development of castration resistance.
Identical capsules as in the atorvastatin arm, but including no active ingredient. Used daily for max. 10 years or until development of castration resistance