Using aspirin and atorvastatin for advanced prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the effects of acetylsalicylic acid (aspirin) and atorvastatin on overall survival in patients with castrate-resistant prostate cancer (CRPC) who are starting first-line treatment. It employs a 2x2 factorial design, meaning participants will be randomly assigned to receive either one or both of the interventions or a placebo. The study aims to determine if these medications can improve survival outcomes for this patient population. It is conducted across multiple international centers to gather diverse data.

Why it matters

Who can join: the full rules

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 and informed consent form signed by the patient.

Exclusion Criteria:

* 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

Where it's running

• Gustave Roussy Cancer Campus Grand Paris
  Villejuif, Val de Marne, France Recruiting
• CHU Besançon Hopital Jean Minjoz
  Besançon, France Recruiting
• Hôpital NOVO
  Cergy-Pontoise, France Recruiting
• Centre Jean Perrin
  Clermont-Ferrand, France Recruiting
• CHU Martinique -Hôpital Clarac
  Fort de France, France Recruiting
• CHU de Pointe à Pitre Abymes
  Guadeloupe, France Recruiting

Study contacts

• Study coordinator: Karim Fizazi, MD, PhD
• Email: karim.fizazi@gustaveroussy.fr
• Phone: +33 (0)1 42 11 43 17

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.