Impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy

Prior treatment

• Previous adverse effects during statin therapy

Other illness

• 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)

Lab values

• 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)
• Hypersensitivity to the active substance (atorvastatin) or to any of the excipients in the atorvastatin product (microcrystalline cellulose, sodium carbonate, maltose, croscarmellose sodium, magnesium stearate, hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80 or titanium dioxide (E171)

Other

• Statin use at the time of recruitment or within 6 months of it

• Histopathologically confirmed metastatic adenocarcinoma of the prostate (radiologically confirmed bone or soft tissue metastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelvic lymph nodes) for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated no longer than 3 months before either as the primary treatment
• High-risk M0 stage prostate cancer recurring after curative-intent primary therapy (surgery or radiotherapy) for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated no longer than 3 months before recruitment. • High risk M0 prostate cancer defined when one of the following criteria fulfilled: o Primarily Gleason 8-10 cancer OR o PSA doubling time ≤ 6 months OR o PSA ≥ 20 ng/ml OR o new lymph node metastases in imaging o previous prostatectomy and radiation therapy allowed o ADT/antiandrogen therapy for neoadjuvant hormone therapy is not included
• Willingness to participate and signing of informed consent