Actively Recruiting
A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents
Led by UNICANCER · Updated on 2026-04-28
300
Participants Needed
95
Research Sites
495 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a Phase III international trial to study the effects and safety of androgen deprivation therapy (ADT) with or without darolutamide in men newly diagnosed with metastatic prostate cancer who have vulnerable functional abilities. This study specifically includes patients who have not chosen treatment with docetaxel or other androgen receptor pathway inhibitors. The goal is to evaluate how these treatments impact disease progression and patient health over time. Participants will be randomly assigned to one of two groups: one receiving ADT plus darolutamide 600 mg taken orally twice daily, and the other receiving ADT plus a placebo taken with the same schedule. Treatment will continue until imaging shows disease progression or until the patient or doctor decides to stop for reasons such as side effects or other health issues. After stopping treatment, patients will enter a follow-up phase lasting up to 10 years to monitor survival, further treatments, and any ongoing or new side effects. During the study, participants will undergo regular assessments including imaging scans to check for cancer progression, blood tests, evaluations of urinary symptoms, and quality of life questionnaires. Researchers will track outcomes like progression-free survival, overall survival, symptom changes, and adverse events. Monitoring visits will occur periodically both during treatment and follow-up to gather comprehensive data on health status and treatment effects.
CONDITIONS
Brief Title
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form before any trial procedures
- Male patients with confirmed adenocarcinoma of the prostate
- Age 18 years or older at consent
- Newly diagnosed metastatic disease shown by clinical or imaging evidence
- For nodal-only metastases, specific size and location criteria of lymph nodes apply
- Measurable disease or bone lesions evaluable by PCWG3 criteria
- Ineligible for docetaxel, abiraterone, enzalutamide, or apalutamide treatment and meet at least one frailty criterion (ADL, IADL, CISR-G score, low BMI or weight loss, or slow timed up and go test)
- Adequate bone marrow function (specific blood counts)
- Adequate liver function with defined limits
- Adequate kidney function with creatinine clearance above 30 ml/min
- Agreement to use adequate contraception if sexually active
- Affiliated with social security or equivalent health insurance
- Willing and able to follow study procedures and visits
You will not qualify if you...
- Three or more Grade 3 or any Grade 4 events on the CISR-G questionnaire
- Poor performance status (ECOG score 3 or higher)
- Uncontrolled hypertension despite treatment
- Unresolved acute toxicities from prior treatments except hot flushes and erectile dysfunction
- Prior systemic prostate cancer treatment except limited ADT or old androgen receptor inhibitors
- Severe or uncontrolled diseases, infections, or co-morbidities
- Known allergy to study treatments
- Major surgery within 28 days before randomization
- Recent serious cardiovascular events within 6 months
- Prior malignancies within 3 years except certain treated skin or localized cancers
- Inability to swallow oral medications
- Gastrointestinal conditions affecting drug absorption
- Active viral hepatitis, HIV, or chronic liver disease
- Use of investigational products within 28 days before randomization
- Participation in another investigational clinical trial
- Legal or psychological conditions limiting study compliance
- Any condition judged by the investigator to prevent participation or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until radiographic disease progression or discontinuation
Participants receive androgen deprivation therapy (ADT) with either darolutamide or placebo until their disease progresses or they stop treatment for other reasons.
Visits on treatment day 1 and every 120 days during the first year, then every 180 days if treatment continues longer
Duration - Up to 10 years
Participants are monitored for survival status, subsequent cancer treatments, and ongoing or new side effects for up to 10 years after treatment ends.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 95 locations
1
Grand Hopital de Charleroi - site Notre Dame
Charleroi, Belgium, 6000
Actively Recruiting
2
Groupe Jolimont - Hôpital De Jolimont
Haine-Saint-Paul, Belgium, 7100
Actively Recruiting
3
CHU UCL NAMUR - Site STE. ELISABETH
Namur, Belgium, 5000
Actively Recruiting
4
Clinique Saint Pierre
Ottignies, Belgium, 1340
Actively Recruiting
5
Institut Sainte Catherine
Avignon, France, 84918
Actively Recruiting
6
Centre Hospitalier Cote basque
Bayonne, France, 64109
Actively Recruiting
7
CHU Besançon - Hopital Jean Mijoz
Besançon, France, 25000
Actively Recruiting
8
Centre Pierre Curie
Beuvry, France, 62660
Actively Recruiting
9
Centre Institut Bergonié
Bordeaux, France, 22076
Actively Recruiting
10
Clinique Pasteur
Brest, France, 29200
Actively Recruiting
11
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
12
Centre Hospitalier Métropole Savoie
Chambéry, France, 73000
Actively Recruiting
13
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
14
CH Colmar
Colmar, France
Actively Recruiting
15
APHP - Hôpital Henri Mondor
Créteil, France, 94010
Actively Recruiting
16
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
17
CHU Grenoble
Grenoble, France, 38043
Actively Recruiting
18
CHU Sud Réunion
La Réunion, France, 97448
Not Yet Recruiting
19
Centre CHV Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
20
CHU le MANS
Le Mans, France, 72000
Actively Recruiting
21
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
22
Polyclinique de Limoges
Limoges, France, 87000
Actively Recruiting
23
Groupe Hospitalier Bretagne Sud
Lorient, France, 56322
Actively Recruiting
24
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
25
Institut Paoli-Calmettes
Marseille, France, 13273
Actively Recruiting
26
CH Mont De Marsan
Mont-de-Marsan, France, 40024
Actively Recruiting
27
Centre Azuréen de Cancérologie
Mougins, France, 06250
Actively Recruiting
28
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
29
CHU Nîmes
Nîmes, France, 30029
Actively Recruiting
30
Centre Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France, 75020
Actively Recruiting
31
Hôpital Saint Louis
Paris, France, 75475
Actively Recruiting
32
Hôpital Européen Georges Pompidou
Paris, France, 75908
Actively Recruiting
33
Hôpital Tenon
Paris, France, 75970
Actively Recruiting
34
Hospices Civils de Lyon -Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
35
CHU de Poitiers - Pôle Régional de Cancérologie
Poitiers, France, 86021
Actively Recruiting
36
CH Annecy Genevois
Pringy, France, 74374
Actively Recruiting
37
CHIC Quimper
Quimper, France, 29107
Actively Recruiting
38
Institut Jean Godinot
Reims, France, 51056
Actively Recruiting
39
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
40
Centre Eugène Marquis - Rennes
Rennes, France
Actively Recruiting
41
Centre Hospitalier Rodez
Rodez, France, 12027
Actively Recruiting
42
CHU Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
43
Hôpital Privé de la Loire
Saint-Etienne, France, 42100
Actively Recruiting
44
CHP Centre Saint Grégoire
Saint-Grégoire, France, 35760
Actively Recruiting
45
Hôpital Instruction des Armées - BEGIN
Saint-Mandé, France, 94160
Actively Recruiting
46
Clinique Sainte Anne - Strasbourg Oncologie Libérale
Strasbourg, France, 67000
Actively Recruiting
47
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67200
Actively Recruiting
48
Hôpital FOCH
Suresnes, France, 92151
Actively Recruiting
49
Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse
Toulon, France, 83056
Actively Recruiting
50
IUCT Oncopole
Toulouse, France, 31059
Actively Recruiting
51
Clinique Pasteur ONCORAD
Toulouse, France, 31076
Actively Recruiting
52
CHRU de Tours -Hôpital Bretonneau
Tours, France, 37044
Actively Recruiting
53
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
54
Gustave Roussy Center
Villejuif, France, 94805
Actively Recruiting
55
Universitätsmedizin Essen Hufelandstraße
Essen, Germany
Suspended
56
St Vincent's University Hospital
Dublin, Ireland, D04 T6F4
Actively Recruiting
57
Tallaght university Hospital
Dublin, Ireland, D24 NR0A
Actively Recruiting
58
Mater Misericordiae University Hospital
Dublin, Ireland
Actively Recruiting
59
Mater Private Hospital
Dublin, Ireland
Actively Recruiting
60
University Hospital Limerick
Limerick, Ireland
Actively Recruiting
61
University of Bari, Policlinico
Bari, Italy, 70124
Suspended
62
FPO IRCCS Candiolo Turin
Candiolo, Italy
Actively Recruiting
63
Azienda Ospedaliera Universitaria Policlinico Riuniti Di Foggia
Foggia, Italy
Actively Recruiting
64
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, Italy, 47014
Actively Recruiting
65
Fondazione IRCSS Istituto Nazionale Tumori
Milan, Italy, 20133
Actively Recruiting
66
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
67
istituto tumori Fondazione "G.Pascale"
Naples, Italy, 80131
Actively Recruiting
68
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Suspended
69
Istituto Clinico Humanitas - IRCCS
Rozzano, Italy, 20089
Actively Recruiting
70
UOC Oncologia Medica
Syracuse, Italy, 96100
Actively Recruiting
71
Santa Chiara Hospital
Trento, Italy, 38122
Actively Recruiting
72
CHU de la Martinique - Hôpital Albert Clarac
Fort-de-France, Martinique, 97200
Not Yet Recruiting
73
Albert Schweizer Hospital
Dordrecht, Netherlands
Not Yet Recruiting
74
Radboudumc - Dutch Uro-Oncology Study Group (DUOS)
Nijmegen, Netherlands
Actively Recruiting
75
Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
Bucharest, Romania
Not Yet Recruiting
76
Amethyst Radiotherapy Center Cluj SRL
Cluj-Napoca, Romania
Not Yet Recruiting
77
Institul Oncologic Cluj-Napoca
Cluj-Napoca, Romania
Actively Recruiting
78
OncoHelp Hospital
Timișoara, Romania
Actively Recruiting
79
Narodny Onkologicky Institut
Bratislava, Slovakia
Actively Recruiting
80
Institut Catala d'Oncologia, Badalona-Hospital Germans Trias i Pujol
Badalona, Spain
Actively Recruiting
81
Hospital Clinic
Barcelona, Spain
Actively Recruiting
82
Hospital del Mar
Barcelona, Spain
Actively Recruiting
83
Vall d'Hebron Institute of Oncology. Vall d'Hebron University Hospital
Barcelona, Spain
Actively Recruiting
84
Institut Català d'Oncologia de Girona
Girona, Spain
Actively Recruiting
85
Centro Integral Oncologico HM Clara Campal
Madrid, Spain
Actively Recruiting
86
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
87
Althaia, Xara Assistencial Universitaria Mansera
Manresa, Spain
Actively Recruiting
88
Fundacion Instituto Valenciano De Oncologia
Valencia, Spain
Actively Recruiting
89
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
90
Skane University Hospital
Malmö, Sweden
Actively Recruiting
91
Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale S.Giovanni
Bellinzona, Switzerland, 6500
Actively Recruiting
92
Kantonsspital Graubünden, Onkologie/ Hämatologie
Chur, Switzerland
Actively Recruiting
93
Cantonal Hospital St.Gallen
Sankt Gallen, Switzerland
Actively Recruiting
94
Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale Italiano di Lugano
Viganello, Switzerland
Actively Recruiting
95
Universitätsspital Zürich - Onkologie
Zurich, Switzerland
Actively Recruiting
Research Team
C
Catherine N LEGER
R
Rachida KHERRAZ
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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