Informations générales (source: ClinicalTrials.gov)
A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer (PEACE-4)
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
juin 2019
mars 2038
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Karim FIZAZI | 15/04/2024 14:33:42 | Contacter | ||
| HOPITAL FOCH | YANN NEUZILLET | 21/10/2024 07:07:09 | Contacter | ||
| HOPITAL NOVO | COLOBY | 04/07/2024 11:05:04 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Delphine Borchiellini, MD | Contact (sur clinicalTrials) | |||
| Centre Azuréen de Cancérologie - 06250 - Mougins - France | Philippe Ronchin, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Hakim Mahammedi, MD | Contact (sur clinicalTrials) | |||
| CHU Besançon Hopital Jean Minjoz - 25000 - Besançon - France | Antoine Thiery-Vuillemin, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Saint Simon - 75960 - Paris - France | Camille Serrate, MD | Contact (sur clinicalTrials) | |||
| Hôpital d'Instruction des Armées Bégin - 94160 - Saint-Mandé - France | Carole Helissey, MD | Contact (sur clinicalTrials) | |||
| Hôpital Privé Sainte Marguerite - 83400 - Hyères - France | Jean-François Berdah, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - 54519 - Vandœuvre-lès-Nancy - France | Julie Egea, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie Lucien Neuwirth - 42271 - Saint-Priest-en-Jarez - France | Aline Guillot, MD | Contact (sur clinicalTrials) | |||
| Institut Jean Godinot - 51726 - Reims - France | Jean-Christophe Eymard, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
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.
- 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.
- 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