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

NCT ID NCT04916613

Disease control Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Sep 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed a written informed consent form prior to any trial specific procedures. 2. Men with histologically or cytologically confirmed adenocarcinoma of the prostate. 3. Aged ≥18 years old at the time of signing informed consent. 4. 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 5. Measurable disease or bone lesions that are evaluable according to PCWG3 criteria. 6. Ineligible for treatment with all of the following drugs: docetaxel, abiraterone, enzalutamide, apalutamide; AND meets at least one of the following frailty criteria: 1. Activities of daily living (ADL) assessment (excluding urinary incontinence question) score 3 or 4/5, or; 2. 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3/4, or; 3. A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire, or; 4. Body mass index (BMI) ≤21 kg/m² and/or \>5% weight loss in the last 6 months, or; 5. Timed up and go test (TUG) \>14 sec. Nota Bene: Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable. 7. Adequate bone marrow function: haemoglobin ≥80 g/L, white blood cells ≥3.0 x10⁹/L and platelets ≥80 x10⁹/L. 8. Adequate liver function: alanine aminotransferase (ALT) \<2 x upper limit of normal (ULN) and bilirubin \<1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). For patients with documented liver metastasis, ALT \<5 x ULN is acceptable. 9. Adequate renal function: calculated creatinine clearance \>30 ml/min (using the Modification of Diet in Renal Disease \[MDRD\] or Chronic Kidney Disease Epidemiology Collaboration \[CKD EPI) method). 10. For sexually active men, agreement to use adequate contraception for the duration of trial participation and up to 2 weeks after completing study treatment. 11. Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials). 12. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up. Exclusion Criteria: 1. 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). 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≥3. 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). 4. 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. 5. Previous systemic treatment for prostate cancer, except less than 12 weeks of ADT and/or an old-generation AR inhibitor. 6. Severe or uncontrolled concurrent disease, infection or co-morbidity. 7. Known hypersensitivity to the study treatment or any of its ingredients. 8. Major surgery within 28 days before randomisation. 9. 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. 10. 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. 11. Inability to swallow oral medications. 12. Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment. 13. Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening. 14. Treatment with any investigational product within 28 days before randomisation. 15. 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). 16. Individual deprived of liberty or placed under the authority of a tutor. 17. Significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition that, in the opinion of the investigator, would preclude participation in this trial.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    95 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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