RecruitingPhase 3NCT03819101

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

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


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

1,210 participants

Start Date

Jun 6, 2019

Study Type

INTERVENTIONAL

Conditions

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) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether two common, inexpensive medications — aspirin (acetylsalicylic acid) and atorvastatin (a cholesterol-lowering drug, commonly known as a statin) — can slow the progression of prostate cancer that is no longer responding to hormone-blocking therapy (called castrate-resistant prostate cancer, or CRPC). **You may be eligible if...** - You have been diagnosed with prostate cancer that has stopped responding to hormone therapy (castrate-resistant prostate cancer, or CRPC) - Your testosterone levels are very low (confirmed by blood test) - You are 18 years or older with a life expectancy of at least 6 months - Your cancer is progressing (rising PSA or changes on imaging) despite hormone therapy - You have not yet received life-prolonging CRPC treatments like abiraterone, enzalutamide, or docetaxel **You may NOT be eligible if...** - You have already received specific advanced prostate cancer treatments (abiraterone, enzalutamide, radium-223, docetaxel, etc.) - You cannot safely take aspirin or statins due to other health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcetylsalicylic acid

100mg

DRUGAtorvastatin

80 mg


Locations(23)

Studentova

Olomouc, Czechia

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, France

CHU Besançon Hopital Jean Minjoz

Besançon, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Azuréen de Cancérologie

Mougins, France

Centre Antoine Lacassagne

Nice, France

Hôpital de la Croix Saint Simon

Paris, France

Institut Jean Godinot

Reims, France

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, France

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

Hôpital Foch

Suresnes, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Cosenza, Italy

NOVOTNA

Bratislava, Slovakia

Klinik Hirslanden Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

Bellinzona Istituto Oncologico

Bellinzona, Switzerland

Kantonsspital Baselland

Bruderholz, Switzerland

Kantansspital Graubündern

Chur, Switzerland

Kantonsspital Münsterlingen

Münsterlingen, Switzerland

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Stadtspital Triemli

Zurich, Switzerland

AYADI

Tunis, Tunisia

View Full Details on ClinicalTrials.gov

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NCT03819101


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