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Metastatic Prostate CancerPhase 3PEACE1NCT01957436

A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

A Phase 3 study testing abiraterone acetate, radiotherapy and Androgen Deprivation Therapy in people with Metastatic Prostate Cancer, run by UNICANCER at 77 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
abiraterone acetate, radiotherapy and Androgen Deprivation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,173 participants
Where
77 sitesin 7 countries
Study dates
13 Nov 2013to Dec 2032
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 or cytologically confirmed adenocarcinoma of the prostate,
  • Metastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:
  • o At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm
  • Patients with ECOG ≤ 1 (patient with PS 2 due to bone pain can be accrued in the trial),
  • Life expectancy of at least 6 months,
  • Male aged ≥ 18 years old and ≤ 80 years old ,
Show all 28Show fewer
  • Hematology values:
  • Hemoglobin ≥ 10.0 g/dL,
  • Platelet count ≥ 100,000/mL,
  • Neutrophil ≥ 1500 cells/mm³
  • Biochemistry values:
  • Renal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min,
  • Serum potassium ≥ 4 mmol/L,
  • Liver function:
  • Serum bilirubin ≤ 1.5 x ULN (except for patients with documented Gilbert's disease),
  • AST and ALT ≤ 1.5 x ULN (and ≤ 5 ULN in case of liver metastases),
  • ALK-P ≤ 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is normal)
  • Patients must have received ADT for a maximum of 3 months before randomization and there must be a minimum of 6 weeks between the start of ADT and the start of Docetaxel,
  • Patients willing and clinically fit to receive Docetaxel which is defined by the following :
  • Patients respecting all inclusion and exclusion criteria And
  • Patients with no contraindication to docetaxel according to the SmPC of the drug And
  • Patients presenting all medical requirements to receive docetaxel according to the investigator's opinion.
  • Patients might have received previous radiation therapy directed to bone lesions,
  • Patients able to take oral medication,
  • Patients who have received the information sheet and signed the informed consent form,
  • Male patients who will receive Docetaxel and/or Abiraterone acetate and have partners of childbearing potential and/or pregnant partners must use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of abiraterone acetate and/or for 6 months after the last dose of Docetaxel
  • Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
  • Patients with a public or a private health insurance coverage, according to local laws for participation in clinical trials.

Who cannot join

  • Patients with previous definitive local treatment directed to the prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are allowed,
  • Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily,
  • Active infection or other medical condition for which prednisone/prednisolone (corticosteroid) use would be contra-indicated,
  • Previously treated with ketoconazole for prostate cancer for more than 7 days,
  • Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of randomization,
Show all 23Show fewer
  • Hypertension not controlled by an anti-hypertensive treatment (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg; 3 consecutive measures taken 5 minutes apart),
  • Severe or moderate hepatic impairment (Child - Pugh class C or B)
  • Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease),
  • History of pituitary or adrenal dysfunction,
  • Clinically known significant heart disease in the past 6 months as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline,
  • Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
  • Patient with unstable pulmonary disease (eg. Pulmonary embolism)
  • Pathological finding consistent with small cell carcinoma of the prostate,
  • History of malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months,
  • Known allergies, hypersensitivity or intolerance to the study drugs or excipients or docetaxel
  • Administration of an investigational therapeutic within 30 days of randomization,
  • Patients already included in another therapeutic trial involving an experimental drug (patient in a non-experimental trial with no modification of the patient's care can be included),
  • Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial,
  • Individual deprived of liberty or placed under the authority of a tutor.
  • Patients with impaired vision should undergo a prompt and complete ophthalmologic examination.
  • Patients with Cystoid Macular Oedema cannot be included due to a potential risk of deterioration associated with docetaxel.
  • Concomitant use of strong CYP3A4 inhibitors (clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin.)

Trial locations and contacts

77 sites in 7 countries.

77 sites in 7 countries

France49 sites

  • Clinique Claude Bernard

    Albi, 81000

  • Institut de cancerologie de l'Ouest

    Angers, 49933

  • Clinique Générale d'Annecy

    Annecy, 74000

  • Institut Sainte Catherine

    Avignon, 84918

  • Centre de la Baie

    Avranches

  • Centre d'Oncologie et de Radiothérapie du Pays Basque

    Bayonne, 64100

  • Chu Jean Minjoz

    Besançon, 25030

  • Centre Pierre Curie

    Beuvry

  • Institut Bergonie

    Bordeaux, 33076

  • Centre François Baclesse

    Caen

  • Centre Hospitalier Alpes Leman

    Contamine-sur-Arve, 74130

  • Chu de Mondor

    Créteil, 94010

  • Centre Leonard de Vinci

    Dechy

  • Centre Georges-François LECLERC

    Dijon, 21079

  • Clinique Sainte Marguerite

    Hyères, 83400

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Clinique Victor Hugo

    Le Mans, 72000

  • Chu de Limoges

    Limoges, 87042

  • Centre Léon Bérard

    Lyon, 69373

  • CHU Lyon Sud

    Lyon

  • Institut Paoli Calmettes

    Marseille, 13273

  • Chu Timone

    Marseille, 13385

  • Hôpital Nord

    Marseille

  • Centre Azuréen de Cancérologie

    Mougins, 06250

  • Centre Catherine de Sienne

    Nantes, 44202

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU Carémeau

    Nîmes, 30029

  • CHR Orléans la source

    Orléans, 45100

  • Institut Curie

    Paris, 75005

  • Hôpital St Louis

    Paris, 75010

  • Hopital TENON

    Paris

  • Chic Quimper

    Quimper, 29107

  • Institut Jean Godinot

    Reims

  • Centre Eugène Marquis

    Rennes, 35042

  • Clinique Armoricaine de radiologie

    Saint-Brieuc, 22015

  • CHU ST ETIENNE - Hôpital Nord

    Saint-Etienne, 44270

  • CHP Saint Grégoire

    Saint-Grégoire, 35760

  • Institut de Cancérologie del'Ouest - site René Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • CENTRE DE CANCEROLOGIE Paris Nord

    Sarcelles

  • Strasbourg Oncologie Libérale

    Strasbourg, 67000

  • Hopitaux du Leman

    Thonon-les-Bains, 74203

  • Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer - Hôpital Sainte Musse

    Toulon, 83056

  • Institut Claudius Regaud

    Toulouse, 31052

  • Clinique Pasteur

    Toulouse, 31076

  • CHU de TOURS Hôpital Bretonneau

    Tours

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

  • Centre d'Oncologie Saint Yves

    Vannes

  • INSTITUT GUSTAVE ROUSSY, Cancer Campus, Grand Paris

    Villejuif, 94805

Other trials in France

Spain11 sites

  • Hospital Germans Trias i Pujol

    Badalona

  • Hospital De la Santa Creu I Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Vall d'Hebron University Hospital

    Barcelona

  • ICO Girona - Hospital Josep Trueta

    Girona

  • Hospital Universitario HM Sanchinarro

    Madrid

  • 'Hospital Clinico Virgen de la Victoria

    Málaga

  • Althaia

    Manresa

  • 'Parc Tauli Sabadell Hospital Universitari

    Sabadell

  • Hospital Universitario de Salamanca

    Salamanca

  • Institut Valenciano de Oncologia

    Valencia

Other trials in Spain

Belgium6 sites

  • Onze Lieve Vrouw Ziekenhuis

    Aalst

  • Hôpitaux Universitaires Bordet Erasme- Institut Jules Bordet

    Brussels

  • Hopital de Jolimont

    Haine-Saint-Paul

  • AZ Groeninge Kortrijk - Campus Vercruysselaan

    Kortrijk

  • Cliniques Universitaires Saint-Luc

    Leuven

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven

Other trials in Belgium

Ireland6 sites

  • Cork University Hospital

    Cork

  • Adelaide and Meath incorporating National Children's hospital department

    Dublin

  • Mater Misericordiae University Hospital

    Dublin

  • Mater Private Hospital

    Dublin

  • St Vincent's University Hospital

    Dublin

  • Galway University Hospital

    Galway

Other trials in Ireland

Italy2 sites

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • San Camillo Forlanini Hospitals

    Roma

Other trials in Italy

Switzerland2 sites

  • Fondation Dr. Henri Dubois-Ferrière Dinu Lipatti

    Geneva

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

Other trials in Switzerland

Romania1 site

  • Sc Radiotherapy Center Cluj SRL

    Cluj-Napoca

Other trials in Romania

About this study

Official title: A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer

This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

Read the detailed description

Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.

The randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.

The randomization will be stratified (by minimization) according to:

  • enrolment center,
  • performance status (0 vs. 1-2)
  • disease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.

CRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).

When the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.

Investigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.

Abiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.

Being tested
abiraterone acetate, radiotherapy, Androgen Deprivation Therapy, Docetaxel
Keywords
prostate, cancer, metastatic hormone-naive, radiotherapy, abiraterone acetate, docetaxel
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abiraterone acetateDrug

    Also called Zytiga

    abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid

  • radiotherapyRadiation

    74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)

  • Androgen Deprivation TherapyOther

    The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy

  • DocetaxelDrug

    6 cycles at 75mg/m²/cycle, one cycle every 3 weeks

Study groups in NCT01957436
Study groupRoleWhat they receive
Arm AActive comparatorandrogen deprivation therapy + docetaxel
Receives: Other: Androgen Deprivation Therapy; Drug: Docetaxel
Arm BExperimentalandrogen deprivation therapy + docetaxel + abiraterone acetate + prednisone
Receives: Drug: abiraterone acetate; Other: Androgen Deprivation Therapy; Drug: Docetaxel
Arm CExperimentalArm A + radiotherapy
Receives: Radiation: radiotherapy; Other: Androgen Deprivation Therapy; Drug: Docetaxel
Arm DExperimentalArm B + radiotherapy
Receives: Drug: abiraterone acetate; Radiation: radiotherapy; Other: Androgen Deprivation Therapy; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Overall and radiographic progression-free survival in patients with metastatic hormone-naïve prostate cancer treated by androgen deprivation therapy and docetaxel

    Measured: 7.5 years after the first inclusion

  2. Survival

    Overall and radiographic progression-free survival in hormone-naïve prostate cancer patients with low metastatic burden whatever the standard of care received

    Measured: 9.5 years after the first inclusion

Secondary outcomes (13)

  1. Castration resistance-free survival (CRFS)

    Measured: 9.5 years after the first inclusion

  2. Serious Genitourinary event-free survival (S-GU-EFS)

    Measured: 9.5 years after the first inclusion

  3. Prostate cancer specific survival

    Measured: 9.5 years after the first inclusion

  4. Time to next skeletal-related event

    Measured: 9.5 years after the first inclusion

  5. PSA response rate

    Measured: 9.5 years after the first inclusion

  6. Prospective correlative study of PSA response/progression at 8 months after initation of ADT

    Measured: 9.5 years after the first inclusion

  7. Time to pain progression

    will be evaluated by questionnaires

    Measured: 9.5 years after the first inclusion

  8. Time to chemotherapy for CRPC

    Measured: 9.5 years after the first inclusion

  9. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: At baseline, 6 months, 18 months, and at the end of treatment (up to 9.5 years)

  10. Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    The FACT-P is a self-assessment questionnaire to estimate the health-related quality of life in men with prostate cancer. This questionnaire, composed of 39 items consists of four subscales: Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), Functional Well-Being (7 items), and prostate cancer subscale (12 items). Subscales are rated on 5-point Likert-type scale (from 0 = "Not at all" to 4 = "Very much"). For all subscales, a higher score represents better quality of life.

    Measured: At baseline, 6 months, 12 months, 18 months, and at the end of treatment (up to 9.5 years)

  11. Toxicity (with a specific focus on the use of long-term low-dose steroids)

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout study completion, up to 9.5 years

  12. Changes in bone mineral density

    X-rays are used to measure how many grams of calcium and other bone minerals are packed into a segment of bone

    Measured: At baseline, 6 months, 12 months, and 24 months

  13. Correlation of biomarkers with outcome

    Correlation of biomarkers with outcome, including the prognostic and predictive value on OS, rPFS and CRFS of a neuro-endocrine differentiation of the prostate cancer in the pathological specimen.

    Measured: 9.5 years after the first inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2013 (estimated)
  2. Study start13 Nov 2013
  3. Primary completion18 Aug 2021
  4. Study completionDec 2032 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
1,173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01957436
Sponsor's protocol ID
UC-0160/1105 GETUG AFU-21
Acronym
PEACE1
Status last verified
Nov 2024
First submitted
24 Sep 2013
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Publications

  • Alyamani N, Clementel E, Sargos P, Blanchard P, Supiot S, Ronchin P, Pommier P, Duberge T, Silva M, Hammoud Y, Hasbini A, Khalifa J, Gnep K, Scrase C, Saez J, Vieillevigne L, Christiaens M, Zilli T, Ribault H, Bossi A, Fizazi K, Andratschke N. Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis. Radiother Oncol. 2025 May;206:110780. doi: 10.1016/j.radonc.2025.110780. Epub 2025 Feb 7.

    PubMed 39924002

  • Roubaud G, Kostine M, McDermott RS, Bernard-Tessier A, Maldonado X, Silva M, Flechon A, Berthold DR, Ronchin P, Tombal BF, Mourey L, Gravis G, Escande A, Abadie-Lacourtoisie S, Maurina T, Climent MA, Ribault H, Bossi A, Foulon S, Fizazi K. Assessment of bone mineral density in men with de novo metastatic castration-sensitive prostate cancer treated with or without abiraterone acetate plus prednisone in the PEACE-1 phase 3 trial. Eur J Cancer. 2025 Mar 11;218:115293. doi: 10.1016/j.ejca.2025.115293. Epub 2025 Feb 6.

    PubMed 39923274

  • Fizazi K, Foulon S, Carles J, Roubaud G, McDermott R, Flechon A, Tombal B, Supiot S, Berthold D, Ronchin P, Kacso G, Gravis G, Calabro F, Berdah JF, Hasbini A, Silva M, Thiery-Vuillemin A, Latorzeff I, Mourey L, Laguerre B, Abadie-Lacourtoisie S, Martin E, El Kouri C, Escande A, Rosello A, Magne N, Schlurmann F, Priou F, Chand-Fouche ME, Freixa SV, Jamaluddin M, Rieger I, Bossi A; PEACE-1 investigators. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 x 2 factorial design. Lancet. 2022 Apr 30;399(10336):1695-1707. doi: 10.1016/S0140-6736(22)00367-1. Epub 2022 Apr 8.

    PubMed 35405085

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing abiraterone acetate, radiotherapy and Androgen Deprivation Therapy in people with Metastatic Prostate Cancer, run by UNICANCER at 77 sites in 7 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 28 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in France, Spain, Belgium, Ireland, Italy and 2 more countries. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 7.5 years after the first inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01957436, which also lists 3 linked publications.

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 12 Nov 2024.

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