A Phase III trial of acetylsalicylic acid and atorvastatin in patients with castrate-resistant prostate cancer (PEACE 4)

Castration-resistant prostate cancer

Overall survival (OS). OS will be calculated from the date of randomization to the date of death (or the last follow-up date in case of censored data).

Prostate cancer specific survival (events including only deaths due to prostate cancer), Progression-Free Survival (including PSA progression by PCWG3 criteria (recommended) or if not by investigator’s assessment), Radiographic Progression-Free Survival (progression defined by PCWG3 criteria), Time to next anticancer treatment, Safety (NCI-CTC V5.0 criteria). G1 to G5 acetylsalicylic acid and statin-related known AEs and all the other events only G3-5., G1 to G5 AEs considered related to acetylsalicylic acid and/or statin and about all others AEs only G3-5 have to be collected., Cardio-vascular morbidity: cardiovascular hospitalization (e.g. stroke, myocardial infarction) and cardio-vascular mortality or any G3/4 cardiovascular AE, Changes from baseline of BMI (BMI=weight (kg)/height (m)2), body weight and waist measure under treatment, Translational research: Metabolic parameters (including baseline lipid profile and change in levels of lipids under treatment), Translational research: Low levels of Vitamin D at baseline, Translational research: LNR (Lymphocyte to Neutrophil Ratio) and CRP, Translational research: Lipid signature

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France