New hope for frail prostate cancer patients: darolutamide combo trial launches

NCT ID NCT04916613

Recruiting now Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether adding darolutamide (Nubeqa) to standard hormone therapy (ADT) helps men with metastatic prostate cancer who are too frail for stronger treatments. About 300 participants will receive either darolutamide or a placebo, plus ADT. The goal is to see if the combination delays cancer growth or death.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Darolutamide (Nubeqa) plus androgen deprivation therapy (ADT)
What this could lead to: If it works, this could offer a new treatment option for vulnerable men with metastatic prostate cancer who cannot tolerate stronger therapies, potentially slowing disease progression.
What could go wrong: This is an early-stage Phase 3 trial with only 300 participants, so results may not apply to all patients. Darolutamide can cause side effects like fatigue, high blood pressure, and falls.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PROSTATE CANCER METASTATIC

Contacts and locations

Locations

APHP - Hôpital Henri Mondor
RECRUITING

Créteil, 94010, France
Albert Schweizer Hospital
NOT_YET_RECRUITING

Dordrecht, Netherlands
Althaia, Xara Assistencial Universitaria Mansera
RECRUITING

Manresa, Spain
Amethyst Radiotherapy Center Cluj SRL
NOT_YET_RECRUITING

Cluj-Napoca, Romania
Azienda Ospedaliera Universitaria Policlinico Riuniti Di Foggia
RECRUITING

Foggia, Italy
CH Annecy Genevois
RECRUITING

Pringy, 74374, France
CH Colmar
RECRUITING

Colmar, France
CH Mont De Marsan
RECRUITING

Mont-de-Marsan, 40024, France
CHIC Quimper
RECRUITING

Quimper, 29107, France
CHP Centre Saint Grégoire
RECRUITING

Saint-Grégoire, 35760, France
CHRU de Tours -Hôpital Bretonneau
RECRUITING

Tours, 37044, France
CHU Besançon - Hopital Jean Mijoz
RECRUITING

Besançon, 25000, France
CHU Grenoble
RECRUITING

Grenoble, 38043, France
CHU Nîmes
RECRUITING

Nîmes, 30029, France
CHU Saint-Etienne
RECRUITING

Saint-Etienne, 42055, France
CHU Sud Réunion
NOT_YET_RECRUITING

La Réunion, 97448, France
CHU UCL NAMUR - Site STE. ELISABETH
RECRUITING

Namur, 5000, Belgium
CHU de Poitiers - Pôle Régional de Cancérologie
RECRUITING

Poitiers, 86021, France
CHU de la Martinique - Hôpital Albert Clarac
NOT_YET_RECRUITING

Fort-de-France, 97200, Martinique
CHU le MANS
RECRUITING

Le Mans, 72000, France
Cantonal Hospital St.Gallen
RECRUITING

Sankt Gallen, Switzerland
Centre Antoine Lacassagne
RECRUITING

Nice, 06189, France
Centre Azuréen de Cancérologie
RECRUITING

Mougins, 06250, France
Centre CHV Vendée
RECRUITING

La Roche-sur-Yon, 85925, France
Centre Eugène Marquis
RECRUITING

Rennes, 35042, France
Centre Eugène Marquis - Rennes
RECRUITING

Rennes, France
Centre François Baclesse
RECRUITING

Caen, 14076, France
Centre Georges François Leclerc
RECRUITING

Dijon, 21079, France
Centre Groupe Hospitalier Diaconesses Croix Saint-Simon
RECRUITING

Paris, 75020, France
Centre Hospitalier Cote basque
RECRUITING

Bayonne, 64109, France
Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse
RECRUITING

Toulon, 83056, France
Centre Hospitalier Métropole Savoie
RECRUITING

Chambéry, 73000, France
Centre Hospitalier Rodez
RECRUITING

Rodez, 12027, France
Centre Institut Bergonié
RECRUITING

Bordeaux, 22076, France
Centre Jean Perrin
RECRUITING

Clermont-Ferrand, 63011, France
Centre Léon Bérard
RECRUITING

Lyon, 69373, France
Centre Oscar Lambret
RECRUITING

Lille, 59000, France
Centre Pierre Curie
RECRUITING

Beuvry, 62660, France
Centro Integral Oncologico HM Clara Campal
RECRUITING

Madrid, Spain
Clinique Pasteur
RECRUITING

Brest, 29200, France
Clinique Pasteur ONCORAD
RECRUITING

Toulouse, 31076, France
Clinique Saint Pierre
RECRUITING

Ottignies, 1340, Belgium
Clinique Sainte Anne - Strasbourg Oncologie Libérale
RECRUITING

Strasbourg, 67000, France
FPO IRCCS Candiolo Turin
RECRUITING

Candiolo, Italy
Fondazione IRCSS Istituto Nazionale Tumori
RECRUITING

Milan, 20133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
SUSPENDED

Roma, 00168, Italy
Fundacion Instituto Valenciano De Oncologia
RECRUITING

Valencia, Spain
Grand Hopital de Charleroi - site Notre Dame
RECRUITING

Charleroi, 6000, Belgium
Groupe Hospitalier Bretagne Sud
RECRUITING

Lorient, 56322, France
Groupe Jolimont - Hôpital De Jolimont
RECRUITING

Haine-Saint-Paul, 7100, Belgium
Gustave Roussy Center
RECRUITING

Villejuif, 94805, France
Hospices Civils de Lyon -Lyon Sud
RECRUITING

Pierre-Bénite, 69310, France
Hospital Clinic
RECRUITING

Barcelona, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, Spain
Hospital del Mar
RECRUITING

Barcelona, Spain
Hôpital Européen Georges Pompidou
RECRUITING

Paris, 75908, France
Hôpital FOCH
RECRUITING

Suresnes, 92151, France
Hôpital Instruction des Armées - BEGIN
RECRUITING

Saint-Mandé, 94160, France
Hôpital Privé de la Loire
RECRUITING

Saint-Etienne, 42100, France
Hôpital Saint Louis
RECRUITING

Paris, 75475, France
Hôpital Tenon
RECRUITING

Paris, 75970, France
Hôpitaux Universitaires de Strasbourg
RECRUITING

Strasbourg, 67200, France
IRCCS Ospedale San Raffaele
RECRUITING

Milan, Italy
IUCT Oncopole
RECRUITING

Toulouse, 31059, France
Institul Oncologic Cluj-Napoca
RECRUITING

Cluj-Napoca, Romania
Institut Catala d'Oncologia, Badalona-Hospital Germans Trias i Pujol
RECRUITING

Badalona, Spain
Institut Català d'Oncologia de Girona
RECRUITING

Girona, Spain
Institut Jean Godinot
RECRUITING

Reims, 51056, France
Institut Paoli-Calmettes
RECRUITING

Marseille, 13273, France
Institut Sainte Catherine
RECRUITING

Avignon, 84918, France
Institut de Cancérologie de Lorraine
RECRUITING

Vandœuvre-lès-Nancy, 54500, France
Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti
NOT_YET_RECRUITING

Bucharest, Romania
Istituto Clinico Humanitas - IRCCS
RECRUITING

Rozzano, 20089, Italy
Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale Italiano di Lugano
RECRUITING

Viganello, Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale S.Giovanni
RECRUITING

Bellinzona, 6500, Switzerland
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
RECRUITING

Meldola, 47014, Italy
Kantonsspital Graubünden, Onkologie/ Hämatologie
RECRUITING

Chur, Switzerland
Mater Misericordiae University Hospital
RECRUITING

Dublin, Ireland
Mater Private Hospital
RECRUITING

Dublin, Ireland
Narodny Onkologicky Institut
RECRUITING

Bratislava, Slovakia
OncoHelp Hospital
RECRUITING

Timișoara, Romania
Polyclinique de Limoges
RECRUITING

Limoges, 87000, France
Radboudumc - Dutch Uro-Oncology Study Group (DUOS)
RECRUITING

Nijmegen, Netherlands
Sahlgrenska University Hospital
RECRUITING

Gothenburg, Sweden
Santa Chiara Hospital
RECRUITING

Trento, 38122, Italy
Skane University Hospital
RECRUITING

Malmö, Sweden
St Vincent's University Hospital
RECRUITING

Dublin, D04 T6F4, Ireland
Tallaght university Hospital
RECRUITING

Dublin, D24 NR0A, Ireland
UOC Oncologia Medica
RECRUITING

Syracuse, 96100, Italy
University Hospital Limerick
RECRUITING

Limerick, Ireland
University of Bari, Policlinico
SUSPENDED

Bari, 70124, Italy
Universitätsmedizin Essen Hufelandstraße
SUSPENDED

Essen, Germany
Universitätsspital Zürich - Onkologie
RECRUITING

Zurich, Switzerland
Vall d'Hebron Institute of Oncology. Vall d'Hebron University Hospital
RECRUITING

Barcelona, Spain
istituto tumori Fondazione "G.Pascale"
RECRUITING

Naples, 80131, Italy

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