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Clinical Trials in Italy / NCT03819101
Recruiting Phase 3

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

NCT03819101 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2019-06-06
Last updated
2026-05-06

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Acetylsalicylic acid →Atorvastatin →

Acetylsalicylic acid: 100mg

Atorvastatin: 80 mg

Study 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
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)

Trial sites (30)

FacilityCityRegionStatus
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 Milan Cosenza Not Yet Recruiting
NOVOTNA Bratislava Slovakia Not Yet Recruiting
Klinik Hirslanden Aarau Aarau Switzerland Withdrawn
Kantonsspital Baden Baden Switzerland Withdrawn
Bellinzona Istituto Oncologico Bellinzona Switzerland Active Not Recruiting
Kantonsspital Baselland Bruderholz Switzerland Withdrawn
Kantansspital Graubündern Chur Switzerland Active Not Recruiting
Kantonsspital Münsterlingen Münsterlingen Switzerland Withdrawn
Kantonsspital St.Gallen Sankt Gallen Switzerland Active Not Recruiting
Stadtspital Triemli Zurich Switzerland Withdrawn
AYADI Tunis Tunisia Not Yet Recruiting

On this site

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Official registry record

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.

View NCT03819101 on ClinicalTrials.gov ↗ ← All trials in Italy