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Using aspirin and atorvastatin for advanced prostate cancer treatment

A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer

Phase 3 Interventional Gustave Roussy, Cancer Campus, Grand Paris · NCT03819101

This study is testing if taking aspirin and atorvastatin together can help men with advanced prostate cancer live longer when they start their first treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1210 (estimated)
Ages18 Years and up
SexMale
SponsorGustave Roussy, Cancer Campus, Grand Paris Academic / other
Locations30 sites (Olomouc and 29 other locations)
Trial IDNCT03819101 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adult men aged 18 and older with histologically confirmed castrate-resistant prostate cancer and a life expectancy of at least six months.

Not a fit: Patients who have previously received life-prolonging treatments for CRPC or those with curative local therapy options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that significantly improves survival rates for patients with advanced prostate cancer.

How similar studies have performed: While the specific combination of acetylsalicylic acid and atorvastatin in this context is novel, previous studies have explored the individual effects of these drugs in cancer treatment with varying degrees of success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Olomouc and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.