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

NCT03819101 | Recruiting Phase 3 DMC

• 2 other identifiers: 2017-004639-352017/2601
• Study Type: interventional
• Target: 1,210
• Locations: 6 countries
• Sites: 30

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS will be calculated from the date of randomization to the date of death up to 15 years

Study Arms (4)

Arm A

NO INTERVENTION

Standard of Care (SOC) for CRPC

Arm B

EXPERIMENTAL

SOC + acetylsalicylic acid 100 mg daily

Drug: Acetylsalicylic acid

Arm C

EXPERIMENTAL

SOC + atorvastatin 80 mg daily

Drug: Atorvastatin

Arm D

EXPERIMENTAL

SOC + acetylsalicylic acid 100 mg daily + atorvastatin 8

Drug: Acetylsalicylic acid; Drug: Atorvastatin

Interventions

Acetylsalicylic acid DRUG

100mg

Arm B; Arm D

Atorvastatin DRUG

80 mg

Arm C; Arm D

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• National Cancer Institute, France: collaborator

Study Sites (30)

Studentova

Olomouc, Czechia

NOT YET RECRUITING

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

RECRUITING

CHU Besançon Hopital Jean Minjoz

Besançon, 25000, France

RECRUITING

Hôpital NOVO

Cergy-Pontoise, 95303, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, 63011, France

RECRUITING

CHU Martinique -Hôpital Clarac

Fort de France, 97261, France

RECRUITING

CHU de Pointe à Pitre Abymes

Guadeloupe, 97139, France

RECRUITING

Centre Azuréen de Cancérologie

Mougins, 06250, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Hôpital de la Croix Saint Simon

Paris, 75960, France

RECRUITING

CHU Poitiers

Poitiers, 86000, France

NOT YET RECRUITING

Institut Jean Godinot

Reims, 51726, France

RECRUITING

CH Roanne

Roanne, 42300, France

NOT YET RECRUITING

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, 94160, France

RECRUITING

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

RECRUITING

Hôpital Foch

Suresnes, 92151, France

RECRUITING

Hôpitaux Du Léman

Thonon-les-Bains, 74200, France

RECRUITING

Hôpital Privé Drôme Ardèche

Valence, 26000, France

NOT YET RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Cosenza, Italy

NOT YET RECRUITING

NOVOTNA

Bratislava, Slovakia

NOT YET RECRUITING

Klinik Hirslanden Aarau

Aarau, 5001, Switzerland

WITHDRAWN

Kantonsspital Baden

Baden, 5404, Switzerland

WITHDRAWN

Bellinzona Istituto Oncologico

Bellinzona, 6500, Switzerland

ACTIVE NOT RECRUITING

Kantonsspital Baselland

Bruderholz, 4101, Switzerland

WITHDRAWN

Kantansspital Graubündern

Chur, 7000, Switzerland

ACTIVE NOT RECRUITING

Kantonsspital Münsterlingen

Münsterlingen, 8596, Switzerland

WITHDRAWN

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

ACTIVE NOT RECRUITING

Stadtspital Triemli

Zurich, 8063, Switzerland

WITHDRAWN

AYADI

Tunis, Tunisia

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Aspirin; Atorvastatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Karim Fizazi, MD, PhD

CONTACT

+33 (0)1 42 11 43 17; karim.fizazi@gustaveroussy.fr

Gwenael Le Teuff

CONTACT

+33 (0)1 42 11 49 55; gwenael.leteuff@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2x2 factorial randomized, multicenter, international, open phase III trial

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: June 6, 2019
• Primary Completion (Estimated): March 1, 2042
• Study Completion (Estimated): March 1, 2042
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

SL (1); IT (1); CH (8); FR (18); TU (1); CZ (1)