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

Prostate Cancer Clinical Trial

— PEACE-4  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819101
• Other study ID #: 2017-004639-35
• Secondary ID: 2017/2601
• Status: Recruiting
• Phase: Phase 3
• Start date: June 6, 2019
• Est. completion date: March 2038

Study information

• Verified date: February 2023
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Karim Fizazi, MD, PhD
• Phone: +33 (0)1 42 11 43 17
• Email: karim.fizazi[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1210
• Est. completion date: March 2038
• Est. primary completion date: March 2034
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Acetylsalicylic acid
100mg
• Atorvastatin
80 mg

Locations

Country	Name	City	State
France	CHU Besançon Hopital Jean Minjoz	Besançon
France	Centre Jean Perrin	Clermont-Ferrand
France	Hôpital Privé Sainte Marguerite	Hyères
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	Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val De Marne
Switzerland	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	Saint Gallen
Switzerland	Stadtspital Triemli	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	National Cancer Institute, France

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		OS will be calculated from the date of randomization to the date of death up to 15 years