Prostate CancerPhase 3PEACE-4NCT03819101
Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
A Phase 3 study testing Acetylsalicylic acid and Atorvastatin in people with Prostate Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 30 sites in 6 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Acetylsalicylic acid and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,210 participants
- Where
- 30 sitesin 6 countries
- Study dates
- 6 Jun 2019to Mar 2042
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
30 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 6 countries
France18 sites, 18 recruiting
- Recruiting
CHU Besançon Hopital Jean Minjoz
Besançon, 25000
Tristan Maurina, MD, tristan.maurina@oncologyfc2.onmicrosoft.com
- Recruiting
Hôpital NOVO
Cergy-Pontoise, 95303
Coloby, MD
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Hakim Mahammedi, MD, +33 (0)4 73 27 81 41, Hakim.MAHAMMEDI@clermont.unicancer.fr
- Recruiting
CHU Martinique -Hôpital Clarac
Fort de France, 97261
Annoney, MD
- Recruiting
CHU de Pointe à Pitre Abymes
Guadeloupe, 97139
KAULANJAN MD
- Recruiting
Centre Azuréen de Cancérologie
Mougins, 06250
Philippe Ronchin, MD, +33 (0)4 92 92 37 37, ronchinp@yahoo.fr
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Delphine Borchiellini, MD, Delphine.BORCHIELLINI@nice.unicancer.fr
- Recruiting
Hôpital de la Croix Saint Simon
Paris, 75960
Camille Serrate, MD, cserrate@hopital-dcss.org
- Not yet recruiting
CHU Poitiers
Poitiers, 86000
EMANBUX, MD
- Recruiting
Institut Jean Godinot
Reims, 51726
Jean-Christophe Eymard, MD, jc.eymard@reims.unicancer.fr
- Not yet recruiting
CH Roanne
Roanne, 42300
lionel Vincent, MD
- Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160
Carole Helissey, MD, +33 (0)1 43 98 53 19, carolehelissey@gmail.com
- Recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271
pierre cornillon, MD, +33 (0)4 77 97 70 34, aline.guillot@icloire.fr
- Recruiting
Hôpital Foch
Suresnes, 92151
Yann Neuzillet, MD, y.neuzillet@hopital-foch.com
- Recruiting
Hôpitaux Du Léman
Thonon-les-Bains, 74200
Elkentaoui, MD
- Not yet recruiting
Hôpital Privé Drôme Ardèche
Valence, 26000
Doublet, MD
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Camille Simon, MD, ca.simon@nancy.unicancer.fr
- Recruiting
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
Karim Fizazi, MD, PhD, +33 (0)1 42 11 43 17, karim.fizazi@gustaveroussy.fr
Anne Sophie Hue, +33 (0)1 42 11 38 90, anne-sophie.hue@gustaveroussy.fr
Switzerland8 sites
- Withdrawn
Klinik Hirslanden Aarau
Aarau, 5001
- Withdrawn
Kantonsspital Baden
Baden, 5404
- Active, not recruiting
Bellinzona Istituto Oncologico
Bellinzona, 6500
- Withdrawn
Kantonsspital Baselland
Bruderholz, 4101
- Active, not recruiting
Kantansspital Graubündern
Chur, 7000
- Withdrawn
Kantonsspital Münsterlingen
Münsterlingen, 8596
- Active, not recruiting
Kantonsspital St.Gallen
Sankt Gallen, 9007
- Withdrawn
Stadtspital Triemli
Zurich, 8063
Czechia1 site, 1 recruiting
- Not yet recruiting
Studentova
Olomouc
HANA STUDENTOVA, MD, hana.studentova@fnol.cz
Italy1 site, 1 recruiting
- Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Cosenza
Giuseppe Procopio, MD, 0223903033 ext. 2122, giuseppe.procopio@istitutotumori.mi.it
Slovakia1 site, 1 recruiting
- Not yet recruiting
NOVOTNA
Bratislava
NOVOTNA HANA, MD, vieramiskovska@yahoo.fr
Tunisia1 site, 1 recruiting
- Not yet recruiting
AYADI
Tunis
MOUNA AYADI, MD, mariem.melliti@eshmoun.com.tn
About this study
Official title: A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
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
- Prostate Cancer
- Being tested
- Acetylsalicylic acid, Atorvastatin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
100mg
AtorvastatinDrug
80 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm A | No intervention | Standard of Care (SOC) for CRPC |
| Arm B | Experimental | SOC + acetylsalicylic acid 100 mg daily Receives: Drug: Acetylsalicylic acid |
| Arm C | Experimental | SOC + atorvastatin 80 mg daily Receives: Drug: Atorvastatin |
| Arm D | Experimental | SOC + acetylsalicylic acid 100 mg daily + atorvastatin 8 Receives: Drug: Acetylsalicylic acid; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: OS will be calculated from the date of randomization to the date of death up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start6 Jun 2019
- Primary completionMar 2042 (estimated)
- Study completionMar 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2x2 factorial randomized, multicenter, international, open phase III trial
- Masking
- None (open label)
- Enrolment
- 1,210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819101
- Sponsor's protocol ID
- 2017-004639-35
- Other IDs
- 2017/2601, 2017
- Acronym
- PEACE-4
- Status last verified
- May 2026
- First submitted
- 24 Jan 2019
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03819101
- Acronym / sponsor ID
- PEACE-4 / 2017-004639-35
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,210 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- Mar 2042 (estimated)
- Study completion
- Mar 2042 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a 2x2 factorial randomized, multicenter, international, open phase III trial
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –Standard of Care (SOC) for CRPC |
| Arm B | Experimental | Drug: Acetylsalicylic acidSOC + acetylsalicylic acid 100 mg daily |
| Arm C | Experimental | Drug: AtorvastatinSOC + atorvastatin 80 mg daily |
| Arm D | Experimental | Drug: Acetylsalicylic acid, Drug: AtorvastatinSOC + acetylsalicylic acid 100 mg daily + atorvastatin 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acid100mg | Drug | Arm B, Arm D |
| Atorvastatin80 mg | Drug | Arm C, Arm D |
Primary outcome
Overall Survival (OS)
Time frame: OS will be calculated from the date of randomization to the date of death up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid and Atorvastatin in people with Prostate Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 30 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France, Switzerland, Czechia, Italy, Slovakia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Fizazi, MD, PhD (+33 (0)1 42 11 43 17, karim.fizazi@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: OS will be calculated from the date of randomization to the date of death up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.