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JOURNAL ONKOLOGIE – STUDIE
PEACE-4

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

Rekrutierend

NCT-Nummer:
NCT03819101

Studienbeginn:
Juni 2019

Letztes Update:
14.02.2023

Wirkstoff:
acetylsalicylic acid, Atorvastatin

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris

Collaborator:
National Cancer Institute, France

Kontakt

Studienlocations
(3 von 20)

Gustave Roussy Cancer Campus Grand Paris
94805 Villejuif
FranceRekrutierend» Google-Maps
Ansprechpartner:
Karim Fizazi, MD, PhD
Phone: +33 (0)1 42 11 43 17
E-Mail: karim.fizazi@gustaveroussy.fr

Anne Sophie Hue
Phone: +33 (0)1 42 11 38 90
E-Mail: anne-sophie.hue@gustaveroussy.fr» Ansprechpartner anzeigen
Institut de Cancérologie Lucien Neuwirth
42271 Saint-Priest-en-Jarez
FranceRekrutierend» Google-Maps
Ansprechpartner:
Aline Guillot, MD
Phone: +33 (0)4 77 97 70 34
E-Mail: aline.guillot@icloire.fr» Ansprechpartner anzeigen
Bellinzona Istituto Oncologico
6500 Bellinzona
SwitzerlandAktiv, nicht rekrutierend» Google-Maps
Kantonsspital Baselland
4101 Bruderholz
SwitzerlandZurückgezogen» Google-Maps
Kantansspital Graubündern
7000 Chur
SwitzerlandAktiv, nicht rekrutierend» Google-Maps
Kantonsspital Münsterlingen
8596 Münsterlingen
SwitzerlandZurückgezogen» Google-Maps
Kantonsspital St.Gallen
9007 Saint Gallen
SwitzerlandAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief 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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - OS will be calculated from the date of randomization to the date of death up to 15 years)

Studien-Arme

  • No Intervention: Arm A
    Standard of Care (SOC) for CRPC
  • Experimental: Arm B
    SOC + acetylsalicylic acid 100 mg daily
  • Experimental: Arm C
    SOC + atorvastatin 80 mg daily
  • Experimental: Arm D
    SOC + acetylsalicylic acid 100 mg daily + atorvastatin 8

Geprüfte Regime

  • Acetylsalicylic acid:
    100mg
  • Atorvastatin:
    80 mg

Quelle: ClinicalTrials.gov


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