Actively Recruiting
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
Led by UNICANCER · Updated on 2026-04-28
300
Participants Needed
95
Research Sites
802 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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 informed consent before any trial procedures
- Male with confirmed adenocarcinoma of the prostate
- At least 18 years old at consent
- Newly diagnosed metastatic prostate cancer confirmed by clinical or imaging evidence
- For nodal metastases only: extra-pelvic enlarged lymph nodes meeting size criteria
- Measurable disease or bone lesions evaluable by PCWG3 criteria
- Ineligible for docetaxel, abiraterone, enzalutamide, and apalutamide treatment
- Meet at least one frailty criterion (ADL, 4-IADL scores, Grade 3 CISR-G event, BMI ≤21 kg/m² or >5% weight loss, timed up and go test >14 sec)
- Adequate bone marrow function (hemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L, platelets ≥80 x10⁹/L)
- Adequate liver function (ALT <2 x ULN and bilirubin <1.5 x ULN; higher ALT allowed with liver metastasis)
- Adequate renal function (creatinine clearance >30 ml/min)
- Sexually active men agree to use contraception during and up to 2 weeks after treatment
- Affiliated with social security or equivalent health insurance
- Willing and able to comply with protocol including treatment and visits
You will not qualify if you...
- Three or more Grade 3 or any Grade 4 events on CISR-G questionnaire
- ECOG performance status of 3 or higher
- Uncontrolled hypertension despite treatment (systolic ≥160 mmHg or diastolic ≥95 mmHg)
- Unresolved acute toxicities from prior treatments above Grade 1 except hot flushes and erectile dysfunction
- Prior systemic prostate cancer treatment except less than 12 weeks of ADT or old-generation AR inhibitor
- Severe or uncontrolled concurrent disease, infection, or co-morbidity
- Known hypersensitivity to study treatments or ingredients
- Major surgery within 28 days before randomization
- Recent (within 6 months) serious cardiovascular events or heart failure NYHA Class III or IV
- Prior malignancy within 3 years except certain treated skin, bladder, localized cancers, or early stage chronic lymphocytic leukemia
- Inability to swallow oral medications
- Gastrointestinal conditions affecting absorption of study drugs
- Active viral hepatitis, HIV, or chronic liver disease at screening
- Treatment with investigational products within 28 days before randomization
- Participation in other investigational clinical trials unless non-experimental
- Deprived of liberty or under legal guardianship
- Significant mental, psychological, familial, sociological, or geographical conditions limiting participation or compliance
AI-Screening
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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
CONTACT
R
Rachida KHERRAZ
CONTACT
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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