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

Recruiting Phase 3 Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,210 (estimated)
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris · Other
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About This Trial

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

Trial Locations
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Eligibility Criteria
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 prog…
Contacts

Karim Fizazi, MD, PhD

+33 (0)1 42 11 43 17

karim.fizazi@gustaveroussy.fr

CONTACT

Gwenael Le Teuff

+33 (0)1 42 11 49 55

gwenael.leteuff@gustaveroussy.fr

CONTACT