Status:
RECRUITING
Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
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
- 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
- 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 or active myopathy or significantly elevated (\> 5 times ULN) CK levels
- History of recent stroke or transient ischemic attack (TIA).
- 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)
- Any serious underlying medical condition (by the investigator's judgement) which could impair the ability of the patient to participate in the trial
- 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
- Psychiatric disorder precluding understanding of information about trial related topics, providing informed consent, or interfering with compliance for oral drug intake
Key Trial Info
Start Date :
June 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2042
Estimated Enrollment :
1210 Patients enrolled
Trial Details
Trial ID
NCT03819101
Start Date
June 6 2019
End Date
March 1 2042
Last Update
June 26 2025
Active Locations (23)
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1
Studentova
Olomouc, Czechia
2
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val De Marne, France, 94805
3
CHU Besançon Hopital Jean Minjoz
Besançon, France, 25000
4
Centre Jean Perrin
Clermont-Ferrand, France, 63011