Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
NCT ID: NCT03819101
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1210 participants
INTERVENTIONAL
2019-06-06
2042-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Arm A
Standard of Care (SOC) for CRPC
No interventions assigned to this group
Arm B
SOC + acetylsalicylic acid 100 mg daily
Acetylsalicylic acid
100mg
Arm C
SOC + atorvastatin 80 mg daily
Atorvastatin
80 mg
Arm D
SOC + acetylsalicylic acid 100 mg daily + atorvastatin 8
Acetylsalicylic acid
100mg
Atorvastatin
80 mg
Interventions
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Acetylsalicylic acid
100mg
Atorvastatin
80 mg
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017/2601
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004639-35
Identifier Type: -
Identifier Source: org_study_id
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