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

NCT01957436 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: UC-0160/1105 GETUG AFU-21
• Study Type: interventional
• Target: 1,173
• Locations: 7 countries
• Sites: 77

Brief 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.

Conditions

Metastatic Prostate Cancer

Keywords

prostate; cancer; metastatic hormone-naive; radiotherapy; abiraterone acetate; docetaxel

Outcome Measures

Primary Outcomes (2)

• Survival

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

  7.5 years after the first inclusion

• Survival

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

  9.5 years after the first inclusion

Secondary Outcomes (13)

• Castration resistance-free survival (CRFS)

  9.5 years after the first inclusion

• Serious Genitourinary event-free survival (S-GU-EFS)

  9.5 years after the first inclusion

• Prostate cancer specific survival

  9.5 years after the first inclusion

• Time to next skeletal-related event

  9.5 years after the first inclusion

• PSA response rate

  9.5 years after the first inclusion

Study Arms (4)

Arm A

ACTIVE COMPARATOR

androgen deprivation therapy + docetaxel

Other: Androgen Deprivation Therapy; Drug: Docetaxel

Arm B

EXPERIMENTAL

androgen deprivation therapy + docetaxel + abiraterone acetate + prednisone

Drug: abiraterone acetate; Other: Androgen Deprivation Therapy; Drug: Docetaxel

Arm C

EXPERIMENTAL

Arm A + radiotherapy

Radiation: radiotherapy; Other: Androgen Deprivation Therapy; Drug: Docetaxel

Arm D

EXPERIMENTAL

Arm B + radiotherapy

Drug: abiraterone acetate; Radiation: radiotherapy; Other: Androgen Deprivation Therapy; Drug: Docetaxel

Interventions

abiraterone acetate DRUG

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

Also known as: Zytiga

Arm B; Arm D

radiotherapy RADIATION

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

Arm C; Arm D

Androgen Deprivation Therapy OTHER

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

Arm A; Arm B; Arm C; Arm D

Docetaxel DRUG

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

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ,
• 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),

You may not qualify if:

• 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.
• 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,
• Hypertension not controlled by an anti-hypertensive treatment (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg; 3 consecutive measures taken 5 minutes apart),

Sponsors & Collaborators

• UNICANCER: lead
• Janssen-Cilag Ltd.: collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• Ipsen: collaborator
• Sanofi: collaborator

Study Sites (77)

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

Location

Hôpitaux Universitaires Bordet Erasme- Institut Jules Bordet

Brussels, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, Belgium

Location

AZ Groeninge Kortrijk - Campus Vercruysselaan

Kortrijk, Belgium

Location

Cliniques Universitaires Saint-Luc

Leuven, Belgium

Location

U.Z. Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

Clinique Claude Bernard

Albi, 81000, France

Location

Institut de cancerologie de l'Ouest

Angers, 49933, France

Location

Clinique Générale d'Annecy

Annecy, 74000, France

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

Centre de la Baie

Avranches, France

Location

Centre d'Oncologie et de Radiothérapie du Pays Basque

Bayonne, 64100, France

Location

Chu Jean Minjoz

Besançon, 25030, France

Location

Centre Pierre Curie

Beuvry, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, France

Location

Centre Hospitalier Alpes Leman

Contamine-sur-Arve, 74130, France

Location

Chu de Mondor

Créteil, 94010, France

Location

Centre Leonard de Vinci

Dechy, France

Location

Centre Georges-François LECLERC

Dijon, 21079, France

Location

Clinique Sainte Marguerite

Hyères, 83400, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Clinique Victor Hugo

Le Mans, 72000, France

Location

Chu de Limoges

Limoges, 87042, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

CHU Lyon Sud

Lyon, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Chu Timone

Marseille, 13385, France

Location

Hôpital Nord

Marseille, France

Location

Centre Azuréen de Cancérologie

Mougins, 06250, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHU Carémeau

Nîmes, 30029, France

Location

CHR Orléans la source

Orléans, 45100, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital St Louis

Paris, 75010, France

Location

Hopital TENON

Paris, France

Location

Chic Quimper

Quimper, 29107, France

Location

Institut Jean Godinot

Reims, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Clinique Armoricaine de radiologie

Saint-Brieuc, 22015, France

Location

CHU ST ETIENNE - Hôpital Nord

Saint-Etienne, 44270, France

Location

CHP Saint Grégoire

Saint-Grégoire, 35760, France

Location

Institut de Cancérologie del'Ouest - site René Gauducheau

Saint-Herblain, 44805, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

CENTRE DE CANCEROLOGIE Paris Nord

Sarcelles, France

Location

Strasbourg Oncologie Libérale

Strasbourg, 67000, France

Location

Hopitaux du Leman

Thonon-les-Bains, 74203, France

Location

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

Toulon, 83056, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CHU de TOURS Hôpital Bretonneau

Tours, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

Centre d'Oncologie Saint Yves

Vannes, France

Location

INSTITUT GUSTAVE ROUSSY, Cancer Campus, Grand Paris

Villejuif, 94805, France

Location

Cork University Hospital

Cork, Ireland

Location

Adelaide and Meath incorporating National Children's hospital department

Dublin, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

Mater Private Hospital

Dublin, Ireland

Location

St Vincent's University Hospital

Dublin, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

Location

San Camillo Forlanini Hospitals

Roma, Italy

Location

Sc Radiotherapy Center Cluj SRL

Cluj-Napoca, Romania

Location

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital De la Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Vall d'Hebron University Hospital

Barcelona, Spain

Location

ICO Girona - Hospital Josep Trueta

Girona, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, Spain

Location

Althaia

Manresa, Spain

Location

'Hospital Clinico Virgen de la Victoria

Málaga, Spain

Location

'Parc Tauli Sabadell Hospital Universitari

Sabadell, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Institut Valenciano de Oncologia

Valencia, Spain

Location

Fondation Dr. Henri Dubois-Ferrière Dinu Lipatti

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 39924002 DERIVED

• 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.

  PMID: 39923274 DERIVED

• 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.

  PMID: 35405085 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Abiraterone Acetate; Radiotherapy; Androgen Antagonists; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Karim FIZAZI, Professor

  Gustave Roussy, Cancer Campus Grand Paris - Paris

  STUDY CHAIR

• Alberto BOSSI, Doctor

  Gustave Roussy, Cancer Campus Grand Paris - Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 8, 2013
• Study Start: November 13, 2013
• Primary Completion: August 18, 2021
• Study Completion (Estimated): December 1, 2032
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (49); RO (1); CH (2); BE (6); IE (6); IT (2); ES (11)