Tests aspirin and atorvastatin in men with castration-resistant prostate cancer
Tests aspirin and atorvastatin in adults with castrate-resistant prostate cancer starting first treatment.
Plain-language title generated from the registry record
Registry title: Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
Key facts
- Where
- Aarau, Baden, Bellinzona, Bruderholz, Chur, Münsterlingen, Sankt Gallen, and Zurich, SwitzerlandSee the 8 sites
- Phase
- Phase 3
Where in Switzerland
- Klinik Hirslanden AarauAarau, SwitzerlandNo longer taking part
- Kantonsspital BadenBaden, SwitzerlandNo longer taking part
- Bellinzona Istituto OncologicoBellinzona, SwitzerlandNo longer taking part
- Kantonsspital BasellandBruderholz, SwitzerlandNo longer taking part
- Kantansspital GraubündernChur, SwitzerlandNo longer taking part
- Kantonsspital MünsterlingenMünsterlingen, SwitzerlandNo longer taking part
- Kantonsspital St. GallenSankt Gallen, SwitzerlandNo longer taking part
- Stadtspital TriemliZurich, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gustave Roussy, Cancer Campus, Grand Paris
- Trial code
- NCT03819101EU 2023-508072-11-00
- Record updated
- 6 May 2026
- Original description
This is a 2x2 factorial randomized, multicenter, international, open phase III trial.Read full original descriptionShow less
A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
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
Inclusion: 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 and informed consent form signed by the patient.
Exclusion: Previous localised malignancy within 2 years with the exception of localized non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic Chronic Lymphocytic Leukemia can be included); Previous metastatic malignancy within 5 years; Patient currently taking daily acetylsalicylic acid or a daily statin within the last 6 months; Any concomitant drugs contraindicated for use with the trial drugs according to the product information (e.g. Fusidic acid, potent inhibitors of CYP3A4 or transport proteins: ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir, telaprevir, saquinavir, darunavir, fosamprenavir, boceprevir, gemfibrozil, fenofibrate, etc); Patients with excessive alcohol intake or history of a relevant liver disease; Known hypersensitivity or intolerance to acetylsalicylic acid or atorvastatin or hypersensitivity to any of its components; Contra-indication to acetylsalicylic acid or atorvastatin according to label, including known high-risk for haemorrhage,; History of recent stroke or transient ischemic attack (TIA); Any serious underlying medical condition (by the investigator's judgement) which could impair the ability of the patient to participate in the trial; Psychiatric disorder precluding understanding of information about trial related topics, providing informed consent, or interfering with compliance for oral drug intake; Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal or cholestasis; History of or active myopathy or significantly elevated (> 5 times ULN) CK levels; Patients with hereditary galactose intolerance, Lapp-lactase deficiency or Glucose-Galactose-malabsorption; Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.