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
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Overall Survival (OS) — OS will be calculated from the date of randomization to the date of death up to 15 years
Trial sites (30)
Facility
City
Region
Status
Studentova
Olomouc
Czechia
Not Yet Recruiting
Gustave Roussy Cancer Campus Grand Paris
Villejuif
Val de Marne
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
Centre Azuréen de Cancérologie
Mougins
France
Recruiting
Centre Antoine Lacassagne
Nice
France
Recruiting
Hôpital de la Croix Saint Simon
Paris
France
Recruiting
CHU Poitiers
Poitiers
France
Not Yet Recruiting
Institut Jean Godinot
Reims
France
Recruiting
CH Roanne
Roanne
France
Not Yet Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé
France
Recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez
France
Recruiting
Hôpital Foch
Suresnes
France
Recruiting
Hôpitaux Du Léman
Thonon-les-Bains
France
Recruiting
Hôpital Privé Drôme Ardèche
Valence
France
Not Yet Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
France
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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