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Could everyday aspirin and statins fight advanced prostate cancer?

NCT ID NCT03819101

Disease control Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether taking aspirin and atorvastatin (a common cholesterol-lowering drug) can help men with castrate-resistant prostate cancer live longer. The study plans to enroll 1210 participants who are starting their first treatment for this advanced stage. Researchers will compare survival rates between those taking the drugs and those not, to see if this simple combination offers a benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acetylsalicylic acid (aspirin) and atorvastatin (a statin)
What this could lead to
If it works, this could offer a simple, low-cost way to extend survival for men with advanced prostate cancer that no longer responds to hormone therapy.
What could go wrong
This is a large phase 3 trial, but the drugs are already widely used for other conditions; their benefit for prostate cancer is unproven. There is a risk of side effects like bleeding or muscle pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Mar 2042

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AYADI

    NOT_YET_RECRUITING

    Tunis, Tunisia

  • Bellinzona Istituto Oncologico

    ACTIVE_NOT_RECRUITING

    Bellinzona, 6500, Switzerland

  • CH Roanne

    NOT_YET_RECRUITING

    Roanne, 42300, France

  • CHU Besançon Hopital Jean Minjoz

    RECRUITING

    Besançon, 25000, France

  • CHU Martinique -Hôpital Clarac

    RECRUITING

    Fort de France, 97261, France

  • CHU Poitiers

    NOT_YET_RECRUITING

    Poitiers, 86000, France

  • CHU de Pointe à Pitre Abymes

    RECRUITING

    Guadeloupe, 97139, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre Azuréen de Cancérologie

    RECRUITING

    Mougins, 06250, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    NOT_YET_RECRUITING

    Milan, Cosenza, Italy

  • Gustave Roussy Cancer Campus Grand Paris

    RECRUITING

    Villejuif, Val de Marne, 94805, France

  • Hôpital Foch

    RECRUITING

    Suresnes, 92151, France

  • Hôpital NOVO

    RECRUITING

    Cergy-Pontoise, 95303, France

  • Hôpital Privé Drôme Ardèche

    NOT_YET_RECRUITING

    Valence, 26000, France

  • Hôpital d'Instruction des Armées Bégin

    RECRUITING

    Saint-Mandé, 94160, France

  • Hôpital de la Croix Saint Simon

    RECRUITING

    Paris, 75960, France

  • Hôpitaux Du Léman

    RECRUITING

    Thonon-les-Bains, 74200, France

  • Institut Jean Godinot

    RECRUITING

    Reims, 51726, France

  • Institut de Cancérologie Lucien Neuwirth

    RECRUITING

    Saint-Priest-en-Jarez, 42271, France

  • Institut de Cancérologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

  • Kantansspital Graubündern

    ACTIVE_NOT_RECRUITING

    Chur, 7000, Switzerland

  • Kantonsspital Baden

    WITHDRAWN

    Baden, 5404, Switzerland

  • Kantonsspital Baselland

    WITHDRAWN

    Bruderholz, 4101, Switzerland

  • Kantonsspital Münsterlingen

    WITHDRAWN

    Münsterlingen, 8596, Switzerland

  • Kantonsspital St.Gallen

    ACTIVE_NOT_RECRUITING

    Sankt Gallen, 9007, Switzerland

  • Klinik Hirslanden Aarau

    WITHDRAWN

    Aarau, 5001, Switzerland

  • NOVOTNA

    NOT_YET_RECRUITING

    Bratislava, Slovakia

  • Stadtspital Triemli

    WITHDRAWN

    Zurich, 8063, Switzerland

  • Studentova

    NOT_YET_RECRUITING

    Olomouc, Czechia

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