ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

NCT04916613 | Recruiting Phase 3 DMC

• 3 other identifiers: UC-GTG-20062022-502425-18-002020-003663-26
• Study Type: interventional
• Target: 300
• Locations: 12 countries
• Sites: 95

Brief Summary

This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.

Conditions

Prostate Cancer Metastatic

Keywords

PEACE 6 -Vulnerable

Outcome Measures

Primary Outcomes (1)

• Radiographic progression-free survival

  Time from randomisation to radiographic progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria or death, whichever occurs first

  From randomisation to radiographic progression or death, up to 18 months

Secondary Outcomes (17)

• Castration-resistant prostate cancer-free survival

  From randomisation to onset of CRPC or death, up to 18 months

• Clinical progression-free survival

  From randomisation to clinical progression or death, up to 18 months

• Overall survival

  From randomization to death from any cause, up to 10 years.

• Frequency and severity of adverse events

  From inclusion until 100 days after last dose of investigational product

• Time to worsening in prostate cancer-related urinary symptoms

  On treatment day 1 and every 120 days during first years of treatment and every 180 days thereafter if treatment is continued for more than 1 year

Study Arms (2)

ADT + darolutamide

EXPERIMENTAL

ADT + darolutamide 600 mg po bid

Drug: Darolutamide 300 mg; Drug: Androgen deprivation therapy

ADT + placebo

PLACEBO COMPARATOR

ADT + placebo po bid

Drug: Placebo; Drug: Androgen deprivation therapy

Interventions

Darolutamide 300 mg DRUG

600 mg po, b.i.d.

Also known as: Nubeqa®

ADT + darolutamide

Placebo DRUG

po, b.i.d.

ADT + placebo

Androgen deprivation therapy DRUG

Use according to local standard of care

Also known as: ADT

ADT + darolutamide; ADT + placebo

Eligibility Criteria

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

You may qualify if:

• Signed a written informed consent form prior to any trial specific procedures.
• Men with histologically or cytologically confirmed adenocarcinoma of the prostate.
• Aged ≥18 years old at the time of signing informed consent.
• De novo metastatic disease defined by clinical or radiological evidence of metastases.
• Note: 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:
• At least one extra-pelvic lymph node ≥2 cm
• At least one extra-pelvic lymph node ≥1 cm if the patients also have at least one pelvic lymph node ≥2 cm
• Measurable disease or bone lesions that are evaluable according to PCWG3 criteria.
• Ineligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria:
• Activities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5, or;
• Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4, or;
• A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire, or;
• Body mass index (BMI) ≤21 kg/m² and/or \>5% weight loss in the last 6 months, or;
• Timed up and go test (TUG) \>14 sec. Nota Bene: Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable.
• Adequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L.

You may not qualify if:

• Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire. Nota Bene: (Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable).
• Eastern Cooperative Oncology Group (ECOG) performance status score ≥3.
• Hypertension not controlled by an anti-hypertensive treatment (systolic blood pressure \[BP\] ≥160 mmHg or diastolic BP ≥95 mmHg; 3 consecutive measures taken 5 minutes apart).
• Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or baseline before randomisation, with the exception of hot flushes and erectile dysfunction.
• Previous systemic treatment for prostate cancer, except less than 12 weeks of ADT and/or an old-generation AR inhibitor.
• Severe or uncontrolled concurrent disease, infection or co-morbidity.
• Known hypersensitivity to the study treatment or any of its ingredients.
• Major surgery within 28 days before randomisation.
• Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
• Prior malignancy ≤3 years before study enrolment. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any localized cancer for which treatment has been completed ≥6 months before randomisation and from which the subject has been disease-free, or for which the risk of relapse is less than 30%, as well as early stage chronic lymphocytic leukaemia that does not require any specific treatment.
• Inability to swallow oral medications.
• Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.
• Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening.
• Treatment with any investigational product within 28 days before randomisation.
• Concurrent participation in another clinical trial involving an investigational product (patients enrolled in non-experimental trials with no modification of the standard of care can be included).

Sponsors & Collaborators

• UNICANCER: lead
• Bayer: collaborator

Study Sites (95)

Grand Hopital de Charleroi - site Notre Dame

Charleroi, 6000, Belgium

RECRUITING

Groupe Jolimont - Hôpital De Jolimont

Haine-Saint-Paul, 7100, Belgium

RECRUITING

CHU UCL NAMUR - Site STE. ELISABETH

Namur, 5000, Belgium

RECRUITING

Clinique Saint Pierre

Ottignies, 1340, Belgium

RECRUITING

Institut Sainte Catherine

Avignon, 84918, France

RECRUITING

Centre Hospitalier Cote basque

Bayonne, 64109, France

RECRUITING

CHU Besançon - Hopital Jean Mijoz

Besançon, 25000, France

RECRUITING

Centre Pierre Curie

Beuvry, 62660, France

RECRUITING

Centre Institut Bergonié

Bordeaux, 22076, France

RECRUITING

Clinique Pasteur

Brest, 29200, France

RECRUITING

Centre François Baclesse

Caen, 14076, France

RECRUITING

Centre Hospitalier Métropole Savoie

Chambéry, 73000, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, 63011, France

RECRUITING

CH Colmar

Colmar, France

RECRUITING

APHP - Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

Centre Georges François Leclerc

Dijon, 21079, France

RECRUITING

CHU Grenoble

Grenoble, 38043, France

RECRUITING

CHU Sud Réunion

La Réunion, 97448, France

NOT YET RECRUITING

Centre CHV Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

CHU le MANS

Le Mans, 72000, France

RECRUITING

Centre Oscar Lambret

Lille, 59000, France

RECRUITING

Polyclinique de Limoges

Limoges, 87000, France

RECRUITING

Groupe Hospitalier Bretagne Sud

Lorient, 56322, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Institut Paoli-Calmettes

Marseille, 13273, France

RECRUITING

CH Mont De Marsan

Mont-de-Marsan, 40024, France

RECRUITING

Centre Azuréen de Cancérologie

Mougins, 06250, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

CHU Nîmes

Nîmes, 30029, France

RECRUITING

Centre Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, 75020, France

RECRUITING

Hôpital Saint Louis

Paris, 75475, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75908, France

RECRUITING

Hôpital Tenon

Paris, 75970, France

RECRUITING

Hospices Civils de Lyon -Lyon Sud

Pierre-Bénite, 69310, France

RECRUITING

CHU de Poitiers - Pôle Régional de Cancérologie

Poitiers, 86021, France

RECRUITING

CH Annecy Genevois

Pringy, 74374, France

RECRUITING

CHIC Quimper

Quimper, 29107, France

RECRUITING

Institut Jean Godinot

Reims, 51056, France

RECRUITING

Centre Eugène Marquis

Rennes, 35042, France

RECRUITING

Centre Eugène Marquis - Rennes

Rennes, France

RECRUITING

Centre Hospitalier Rodez

Rodez, 12027, France

RECRUITING

CHU Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

Hôpital Privé de la Loire

Saint-Etienne, 42100, France

RECRUITING

CHP Centre Saint Grégoire

Saint-Grégoire, 35760, France

RECRUITING

Hôpital Instruction des Armées - BEGIN

Saint-Mandé, 94160, France

RECRUITING

Clinique Sainte Anne - Strasbourg Oncologie Libérale

Strasbourg, 67000, France

RECRUITING

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67200, France

RECRUITING

Hôpital FOCH

Suresnes, 92151, France

RECRUITING

Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse

Toulon, 83056, France

RECRUITING

IUCT Oncopole

Toulouse, 31059, France

RECRUITING

Clinique Pasteur ONCORAD

Toulouse, 31076, France

RECRUITING

CHRU de Tours -Hôpital Bretonneau

Tours, 37044, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Gustave Roussy Center

Villejuif, 94805, France

RECRUITING

Universitätsmedizin Essen Hufelandstraße

Essen, Germany

SUSPENDED

St Vincent's University Hospital

Dublin, D04 T6F4, Ireland

RECRUITING

Tallaght university Hospital

Dublin, D24 NR0A, Ireland

RECRUITING

Mater Misericordiae University Hospital

Dublin, Ireland

RECRUITING

Mater Private Hospital

Dublin, Ireland

RECRUITING

University Hospital Limerick

Limerick, Ireland

RECRUITING

University of Bari, Policlinico

Bari, 70124, Italy

SUSPENDED

FPO IRCCS Candiolo Turin

Candiolo, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Riuniti Di Foggia

Foggia, Italy

RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, 47014, Italy

RECRUITING

Fondazione IRCSS Istituto Nazionale Tumori

Milan, 20133, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

istituto tumori Fondazione "G.Pascale"

Naples, 80131, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

SUSPENDED

Istituto Clinico Humanitas - IRCCS

Rozzano, 20089, Italy

RECRUITING

UOC Oncologia Medica

Syracuse, 96100, Italy

RECRUITING

Santa Chiara Hospital

Trento, 38122, Italy

RECRUITING

CHU de la Martinique - Hôpital Albert Clarac

Fort-de-France, 97200, Martinique

NOT YET RECRUITING

Albert Schweizer Hospital

Dordrecht, Netherlands

NOT YET RECRUITING

Radboudumc - Dutch Uro-Oncology Study Group (DUOS)

Nijmegen, Netherlands

RECRUITING

Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti

Bucharest, Romania

NOT YET RECRUITING

Amethyst Radiotherapy Center Cluj SRL

Cluj-Napoca, Romania

NOT YET RECRUITING

Institul Oncologic Cluj-Napoca

Cluj-Napoca, Romania

RECRUITING

OncoHelp Hospital

Timișoara, Romania

RECRUITING

Narodny Onkologicky Institut

Bratislava, Slovakia

RECRUITING

Institut Catala d'Oncologia, Badalona-Hospital Germans Trias i Pujol

Badalona, Spain

RECRUITING

Hospital Clinic

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Vall d'Hebron Institute of Oncology. Vall d'Hebron University Hospital

Barcelona, Spain

RECRUITING

Institut Català d'Oncologia de Girona

Girona, Spain

RECRUITING

Centro Integral Oncologico HM Clara Campal

Madrid, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Althaia, Xara Assistencial Universitaria Mansera

Manresa, Spain

RECRUITING

Fundacion Instituto Valenciano De Oncologia

Valencia, Spain

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Skane University Hospital

Malmo, Sweden

RECRUITING

Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale S.Giovanni

Bellinzona, 6500, Switzerland

RECRUITING

Kantonsspital Graubünden, Onkologie/ Hämatologie

Chur, Switzerland

RECRUITING

Cantonal Hospital St.Gallen

Sankt Gallen, Switzerland

RECRUITING

Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale Italiano di Lugano

Viganello, Switzerland

RECRUITING

Universitätsspital Zürich - Onkologie

Zurich, Switzerland

RECRUITING

MeSH Terms

Interventions

darolutamide; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Karim Fizazi, MD

  Gustave Roussy Cancer Campus, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine N LEGER

CONTACT

+33 (0) 1 85 34 31 13; c-leger@unicancer.fr

Rachida KHERRAZ

CONTACT

+33 (0) 1 80 50 15 99; r-kherraz@unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded placebo controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, international, multicenter, randomized, double-blind

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 7, 2021
• Study Start: April 19, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2037
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After primary analysis until end of trial
• Access Criteria: Steering committee approval

Locations

MA (1); CH (5); BE (4); SE (2); IT (11); RO (4); ES (9); NL (2); SL (1); FR (50); IE (5); DE (1)