This is a 2x2 factorial randomized, multicenter, international, open phase III trial.
The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate and no curative local therapy considered possible
* Age ≥ 18 years, life expectancy of at least 6 months
* CRPC defined as tumor progression (PSA increase on at least 2 separate values separated by at least 1 week or progression on imaging) while on Androgen Deprivation Therapy (orchiectomy, LHRH agonist or -antagonist) with documented serum testosterone levels ≤ 1.7 nmol/L (≤ 0.50 ng/mL). Ongoing concurrent use of LHRH agonist or antagonist is required if the patient has not been surgically castrated
* Presence (M1) or absence (M0) of metastases on imaging
* Performance status 0, 1 or 2
* No previous use of life- prolonging treatments for CRPC (including abiraterone, enzalutamide, radium-223, docetaxel, cabazitaxel, and sipuleucel-T). The use of these agents together with Androgen Deprivation Therapy (ADT) for castrate-sensitive disease is allowed.
* Adequate renal function within 30 days prior to registration: calculated creatinine clearance ≥ 50 mL/min, according to the formula of Cockcroft-Gault and adequate liver function with levels of AST and ALT ≤ 3xULN and no signs for cholestasis.
* Participation in other clinical trials is allowed except for trials with the same primary endpoint, i.e. OS
* Patient authorized to participate to a clinical trial by specific country regulation (eg patient affiliated to a social security system or beneficiary of the same)
* Information delivered to patient an…
What they're measuring
1
Overall Survival (OS)
Timeframe: OS will be calculated from the date of randomization to the date of death up to 15 years