Actively Recruiting
Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2026-05-06
1210
Participants Needed
30
Research Sites
1186 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate with no possible curative local therapy
- Age 18 years or older with life expectancy of at least 6 months
- Castrate-resistant prostate cancer with tumor progression while on androgen deprivation therapy and serum testosterone levels 64 1.7 nmol/L
- Presence or absence of metastases confirmed by imaging
- Performance status 0, 1, or 2
- No previous life-prolonging treatments for CRPC
- Adequate kidney function (creatinine clearance 64 50 mL/min) and liver function (AST and ALT 64 3x upper limit of normal) within 30 days prior to registration
- Participation in other clinical trials allowed except those with overall survival as the primary endpoint
- Authorization to participate by specific country regulations
- Informed consent signed after receiving study information
You will not qualify if you...
- Previous localized malignancy within 2 years except localized non-melanoma skin cancer and certain bladder cancers
- Previous metastatic malignancy within 5 years
- Current daily use of acetylsalicylic acid or statins within the last 6 months
- Active liver disease or unexplained persistent liver enzyme elevations exceeding 3 times the upper limit of normal
- Excessive alcohol intake or history of relevant liver disease
- Known allergy or intolerance to acetylsalicylic acid or atorvastatin
- Contraindications to trial drugs including high risk of bleeding
- History or active myopathy or significantly elevated creatine kinase levels
- History of recent stroke or transient ischemic attack
- Use of contraindicated medications with trial drugs
- Serious medical conditions affecting participation
- Hereditary galactose intolerance, Lapp-lactase deficiency, or glucose-galactose malabsorption
- Inability to comply with medical follow-up
- Psychiatric disorders interfering with consent or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Studentova
Olomouc, Czechia
Not Yet Recruiting
2
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, France, 94805
Actively Recruiting
3
CHU Besançon Hopital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
4
Hôpital NOVO
Cergy-Pontoise, France, 95303
Actively Recruiting
5
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
6
CHU Martinique -Hôpital Clarac
Fort de France, France, 97261
Actively Recruiting
7
CHU de Pointe à Pitre Abymes
Guadeloupe, France, 97139
Actively Recruiting
8
Centre Azuréen de Cancérologie
Mougins, France, 06250
Actively Recruiting
9
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
10
Hôpital de la Croix Saint Simon
Paris, France, 75960
Actively Recruiting
11
CHU Poitiers
Poitiers, France, 86000
Not Yet Recruiting
12
Institut Jean Godinot
Reims, France, 51726
Actively Recruiting
13
CH Roanne
Roanne, France, 42300
Not Yet Recruiting
14
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, France, 94160
Actively Recruiting
15
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42271
Actively Recruiting
16
Hôpital Foch
Suresnes, France, 92151
Actively Recruiting
17
Hôpitaux Du Léman
Thonon-les-Bains, France, 74200
Actively Recruiting
18
Hôpital Privé Drôme Ardèche
Valence, France, 26000
Not Yet Recruiting
19
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
20
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Cosenza, Italy
Not Yet Recruiting
21
NOVOTNA
Bratislava, Slovakia
Not Yet Recruiting
22
Klinik Hirslanden Aarau
Aarau, Switzerland, 5001
Withdrawn
23
Kantonsspital Baden
Baden, Switzerland, 5404
Withdrawn
24
Bellinzona Istituto Oncologico
Bellinzona, Switzerland, 6500
Active, Not Recruiting
25
Kantonsspital Baselland
Bruderholz, Switzerland, 4101
Withdrawn
26
Kantansspital Graubündern
Chur, Switzerland, 7000
Active, Not Recruiting
27
Kantonsspital Münsterlingen
Münsterlingen, Switzerland, 8596
Withdrawn
28
Kantonsspital St.Gallen
Sankt Gallen, Switzerland, 9007
Active, Not Recruiting
29
Stadtspital Triemli
Zurich, Switzerland, 8063
Withdrawn
30
AYADI
Tunis, Tunisia
Not Yet Recruiting
Research Team
K
Karim Fizazi, MD, PhD
CONTACT
G
Gwenael Le Teuff
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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