Clinical trial • Phase III • Oncology

DAROLUTAMIDE for Castration-resistant prostate cancer|Oligometastatic prostate cancer

Phase III trial of DAROLUTAMIDE for Castration-resistant prostate cancer|Oligometastatic prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Castration-resistant prostate cancer|Oligometastatic prostate cancer
Trial Stage
Phase III
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
20-02-2024
First CTIS Authorization Date
03-06-2024

Trial design

Randomised, darolutamide (nubeqa 300 mg film-coated tablets / bay 1841788) alone; and stereotactic body radiation therapy combined with darolutamide (combination arm). dose/schedule not specified in the available trial documents.-controlled Phase III trial across 44 sites in France, Belgium, Ireland and others.

Randomised
Yes
Comparator
Darolutamide (NUBEQA 300 mg film-coated tablets / BAY 1841788) alone; and stereotactic body radiation therapy combined with darolutamide (combination arm). Dose/schedule not specified in the available trial documents.
Target Sample Size
287
Trial Duration For Participant
2922

Eligibility

Recruits 287 Written informed consent is required prior to any trial procedures. "When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent." Persons deprived of their liberty or under protective custody or guardianship are explicitly excluded. The trial population is adults only (≥18 years); no paediatric/assent procedures described..

Vulnerable Population
Written informed consent is required prior to any trial procedures. "When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent." Persons deprived of their liberty or under protective custody or guardianship are explicitly excluded. The trial population is adults only (≥18 years); no paediatric/assent procedures described.

Inclusion criteria

  • {"criterion_text":"- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent.\n- Patients aged ≥18 years.\n- Patient with histologically confirmed of adenocarcinoma prostate cancer without small cell or pure endocrine features.\n- Patient with a history of local treatment with curative intent for localised prostate cancer, including surgery or radiotherapy.\n- Patients with castration resistant prostate cancer, defined with with a combination of Castrate level of testosterone: testosterone < 50ng/dl or 1.7 nmol/L. AND at least one of the following conditions: An increasing PSA level, confirmed in 3 consecutive assessments performed at least 1 week apart despite androgen deprivation therapy; • Tumour progression of soft tissue according to the response criteria in solid tumours (RECIST) version (v)1.1; • Tumour progression on bone scan, according to PCWG3 criteria.\n- Detection of 1 to 5 metastatic sites (pelvic lymph nodes included) on new generation PET using either choline, fluciclovine, or PSMA as tracer;\n- All metastatic sites must be amenable to stereotactic radiation therapy.\n- Patient with normal haematological function: absolute neutrophil count (ANC) >1.0 x 10^9/L, platelets count ≥100 x 10^9/L, and haemoglobin ≥9.0 g/dL.\n- Patient with normal liver function with total bilirubin ≤1.5 upper limit of normal (ULN) (unless documented Gilbert’s syndrome), ASAT and ALAT ≤2.5 ULN (≤5 ULN in the presence of liver metastases).\n- Adequate liver function with bilirubin <3 mg/dL and albumin >2.5 g/dL.\n- Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg, as documented at baseline. Patients with hypertension are eligible if their hypertension is controlled and they meet all other eligibility criteria.\n- Adequate kidney function with a creatinine clearance >30 mL/min (Cockcroft-Gault).\n- Patient with Eastern Cooperative Oncology group (ECOG) performance status (PS) ≤1.\n- Patient is willing to use contraceptive during and for at least 1 week after discontinuing darolutamide.\n- Patient affiliated to the social security system (or equivalent according to local regulations for participation in clinical trials).\n- Patient is 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

  • {"criterion_text":"- Patient previously treated for metastatic castrate-resistant prostate cancer with chemotherapy or immunotherapy. Patients who received prior NHA are eligible provided: - they did not progress on previous NHA - they progressed on previous NHA and chemotherapy is not indicated by investigator\n- A history of cancer, other than the prostate cancer under study, within the 3 years prior to study inclusion, excluding cured localised cancer such as non-melanomatous skin cancer and non-muscle invasive bladder cancer.\n- Presence of an uncontrolled disease or affection that according to the investigator will hinder compliance with the trial procedures or requires hospitalisation.\n- Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening\n- Patients with known allergy or severe hypersensitivity to the study treatment or any of its excipients.\n- Inability and/or difficulty to swallow oral medications.\n- Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment.\n- 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.\n- Patients participating in another therapeutic trial within the 30 days prior to randomisation.\n- Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.\n- Person deprived of their liberty or under protective custody or guardianship."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The superiority of stereotactic body radiation therapy combined with darolutamide to darolutamide alone for patients with CRPC having 1 to 5 oligometastases will be assessed using radiographic progression-free survival (rPFS).","definition_or_measurement_approach":"rPFS is defined as the time from randomisation to radiographic progression of cancer by conventional imaging (CT or bone scan) or death from any cause, whichever occurs first."}

Secondary endpoints

  • {"endpoint_text":"- Safety/tolerance will be assessed according to the incidence of AEs (graded using the NCI CTCAE v5.0).\n- Efficacy will be assessed using the Overall survival (OS), Time to treatment failure (TTF), Prostate cancer-specific survival, Time to PSA progression, Biochemical response rate, Time to next symptomatic skeletal event (SSE), Time to pain progression and Quality of life.","definition_or_measurement_approach":"Safety/tolerance: incidence of adverse events graded per NCI CTCAE v5.0. Efficacy measures: OS, TTF, prostate cancer-specific survival, time to PSA progression, biochemical response rate, time to next symptomatic skeletal event (SSE), time to pain progression, and QoL (measured using FACT-P questionnaire)."}

Recruitment

Planned Sample Size
287
Recruitment Window Months
96
Consent Approach
Written informed consent required prior to any trial-specific procedures. If a patient is physically unable to provide written consent, a trusted person of their choice (independent from investigator and sponsor) may confirm the patient's consent in writing. Trial enrols adults (≥18). Informed consent and subject information forms are available in multiple languages (documents available in French, Dutch, English and Spanish as per submitted ICF/SIS documents).

Geography

Total Number Of Sites
44
Total Number Of Participants
287

France

Earliest CTIS Part Ii Submission Date
15-04-2024
Latest Decision Or Authorization Date
26-09-2025
Processing Time Days
529
Number Of Sites
29
Number Of Participants
195

Sites

Site Name
Hopital Prive Drome-Ardeche
Department Name
Oncologie Médicale
Principal Investigator Name
Louis DOUBLET
Principal Investigator Email
l.doublet@ramsaygds.fr
Contact Person Name
Louis DOUBLET
Contact Person Email
l.doublet@ramsaygds.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Radiothérapie
Principal Investigator Name
Anne BAREILLE
Principal Investigator Email
Anne.Bareille@chu-st-etienne.fr
Contact Person Name
Anne BAREILLE
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie Radiothérapie
Principal Investigator Name
Stéphane SUPIOT
Principal Investigator Email
stephane.supiot@ico.unicancer.fr
Contact Person Name
Stéphane SUPIOT
Site Name
Centre Francois Baclesse
Department Name
Radiothérapie
Principal Investigator Name
Nazim KHALLADI
Principal Investigator Email
n.khalladi@baclesse.unicancer.fr
Contact Person Name
Nazim KHALLADI
Site Name
Institut Gustave Roussy
Department Name
Oncologie Médicale
Principal Investigator Name
Ronan FLIPPOT
Principal Investigator Email
ronan.flippot@gustaveroussy.fr
Contact Person Name
Ronan FLIPPOT
Contact Person Email
ronan.flippot@gustaveroussy.fr
Site Name
Hopital Prive Clairval
Department Name
Radiothérapie
Principal Investigator Name
Emmanuel GROSS
Principal Investigator Email
drgross@free.fr
Contact Person Name
Emmanuel GROSS
Contact Person Email
drgross@free.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Oncologie Radiothérapie
Principal Investigator Name
Jonathan KHALIFA
Principal Investigator Email
khalifa.jonathan@iuct-oncopole.fr
Contact Person Name
Jonathan KHALIFA
Site Name
Institut De Cancerologie De Lorraine
Department Name
Radiothérapie
Principal Investigator Name
Mathilde CUENIN
Principal Investigator Email
m.cuenin@nancy.unicancer.fr
Contact Person Name
Mathilde CUENIN
Contact Person Email
m.cuenin@nancy.unicancer.fr
Site Name
Institut Paoli-Calmettes
Department Name
Oncologie
Principal Investigator Name
Mathilde GUERIN
Principal Investigator Email
GUERINM2@ipc.unicancer.fr
Contact Person Name
Mathilde GUERIN
Contact Person Email
GUERINM2@ipc.unicancer.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Radiothérapie
Principal Investigator Name
Manon BATY
Principal Investigator Email
m.baty@rennes.unicancer.fr
Contact Person Name
Manon BATY
Contact Person Email
m.baty@rennes.unicancer.fr
Site Name
Centre azureen de cancerologie
Department Name
Radiothérapie
Principal Investigator Name
Philippe RONCHIN
Principal Investigator Email
ronchinp@yahoo.fr
Contact Person Name
Philippe RONCHIN
Contact Person Email
ronchinp@yahoo.fr
Site Name
Institut Bergonie
Department Name
Oncologie
Principal Investigator Name
Paul SARGOS
Principal Investigator Email
p.sargos@bordeaux.unicancer.fr
Contact Person Name
Paul SARGOS
Contact Person Email
p.sargos@bordeaux.unicancer.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Radiothérapie
Principal Investigator Name
Inès MENOUX
Principal Investigator Email
i.menoux@icans.eu
Contact Person Name
Inès MENOUX
Contact Person Email
i.menoux@icans.eu
Site Name
Groupe Hospitalier Bretagne Sud
Department Name
Oncologie Radiothérapie
Principal Investigator Name
Guillaume BERA
Principal Investigator Email
g.bera@ghbs.bzh
Contact Person Name
Guillaume BERA
Contact Person Email
g.bera@ghbs.bzh
Site Name
Centre Leon Berard
Department Name
Oncologie Médicale
Principal Investigator Name
Aude FLECHON
Principal Investigator Email
aude.flechon@lyon.unicancer.fr
Contact Person Name
Aude FLECHON
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Oncologie Médicale
Principal Investigator Name
Tiffany DARBAS
Principal Investigator Email
Tiffany.DARBAS@chu-limoges.fr
Contact Person Name
Tiffany DARBAS
Contact Person Email
Tiffany.DARBAS@chu-limoges.fr
Site Name
Clinique Generale
Department Name
Oncologie Radiothérapie
Principal Investigator Name
Anne DONEUX
Principal Investigator Email
annedoneux@hotmail.com
Contact Person Name
Anne DONEUX
Contact Person Email
annedoneux@hotmail.com
Site Name
Institut De Cancerologie De L Ouest (Angers)
Department Name
Oncologie Médicale
Principal Investigator Name
Elouen BOUGHALEM
Principal Investigator Email
elouen.boughalem@ico.unicancer.fr
Contact Person Name
Elouen BOUGHALEM
Site Name
Sainte Catherine Institut Du Cancer Avignon-Provence
Department Name
Oncologie Radiothérapie
Principal Investigator Name
Lysian CARTIER
Principal Investigator Email
l.cartier@isc84.org
Contact Person Name
Lysian CARTIER
Contact Person Email
l.cartier@isc84.org
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Oncologie Médicale
Principal Investigator Name
Nadine HOUEDE
Principal Investigator Email
nadine.houede@chu-nimes.fr
Contact Person Name
Nadine HOUEDE
Contact Person Email
nadine.houede@chu-nimes.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Radiothérapie
Principal Investigator Name
Elisabeth DENIAUD-ALEXANDRE
Principal Investigator Email
elisabeth.deniaud-alexandre@ght85.fr
Contact Person Name
Elisabeth DENIAUD-ALEXANDRE
Site Name
Clinique Pasteur Lanroze
Department Name
Oncologie Radiothérapie
Principal Investigator Name
Ali HASBINI
Principal Investigator Email
nhasbini@vivalto-sante.com
Contact Person Name
Ali HASBINI
Contact Person Email
nhasbini@vivalto-sante.com
Site Name
Centre De Radiotherapie Guillaume Le Conquerant
Department Name
Oncologie Radiothérapie
Principal Investigator Name
Paul LESUEUR
Principal Investigator Email
p.lesueur@cglc.fr
Contact Person Name
Paul LESUEUR
Contact Person Email
p.lesueur@cglc.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie
Principal Investigator Name
Magali QUIVRIN
Principal Investigator Email
mquivrin@cgfl.fr
Contact Person Name
Magali QUIVRIN
Contact Person Email
mquivrin@cgfl.fr
Site Name
Centre Jean Perrin
Department Name
Oncologie Médicale
Principal Investigator Name
Hakim MAHAMMEDI
Principal Investigator Email
hakim.mahammedi@clermont.unicancer.fr
Contact Person Name
Hakim MAHAMMEDI
Site Name
Besancon University Hospital Center
Department Name
Oncologie Médicale
Principal Investigator Name
Tristan MAURINA
Principal Investigator Email
t1maurina@chu-besancion.fr
Contact Person Name
Tristan MAURINA
Contact Person Email
t1maurina@chu-besancion.fr
Site Name
Strasbourg Oncologie Libérale - Clinique Sainte-Anne
Department Name
Oncologie Médicale
Principal Investigator Name
Louis Marie DOURTHE
Principal Investigator Email
LMDOURTHE@solcrr.org
Contact Person Name
Louis Marie DOURTHE
Contact Person Email
LMDOURTHE@solcrr.org
Site Name
L'Hopital Prive Du Confluent (Nantes)
Department Name
Radiothérapie
Principal Investigator Name
Christophe BLAY
Principal Investigator Email
Dr.BLAY.Christophe@groupeconfluent.fr
Contact Person Name
Christophe BLAY
Site Name
L'Hopital Prive Du Confluent (duplicate entry)
Department Name
Radiothérapie
Principal Investigator Name
Christophe BLAY
Principal Investigator Email
Dr.BLAY.Christophe@groupeconfluent.fr
Contact Person Name
Christophe BLAY
Site Name
Centre Hospitalier Lyon Sud
Department Name
Radiothérapie
Principal Investigator Name
Olivier CHAPET
Principal Investigator Email
Olivier.chapet@chu-lyon.fr
Contact Person Name
Olivier CHAPET
Contact Person Email
Olivier.chapet@chu-lyon.fr
Site Name
Centre Oscar Lambret
Department Name
Radiothérapie
Principal Investigator Name
David PASQUIER
Principal Investigator Email
d-pasquier@o-lambret.fr
Contact Person Name
David PASQUIER
Contact Person Email
d-pasquier@o-lambret.fr

Belgium

Earliest CTIS Part Ii Submission Date
19-03-2025
Latest Decision Or Authorization Date
26-09-2025
Processing Time Days
191
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Oncology
Principal Investigator Name
Piet OST
Principal Investigator Email
piet.ost@gza.be
Contact Person Name
Piet OST
Contact Person Email
piet.ost@gza.be
Site Name
CHU Helora
Department Name
Oncology
Principal Investigator Name
Guillaume GRISAY
Principal Investigator Email
guillaume.grisay@helora.be
Contact Person Name
Guillaume GRISAY
Contact Person Email
guillaume.grisay@helora.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Principal Investigator Name
Bertrand TOMBAL
Principal Investigator Email
bertrand.tombal@saintluc.uclouvain.be
Contact Person Name
Bertrand TOMBAL

Ireland

Earliest CTIS Part Ii Submission Date
18-03-2025
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
198
Number Of Sites
3
Number Of Participants
19

Sites

Site Name
Bon Secours Hospital Cork
Department Name
Oncology
Principal Investigator Name
Paul KELLY
Principal Investigator Email
kellyp6@upmc.ie
Contact Person Name
Paul KELLY
Contact Person Email
kellyp6@upmc.ie
Site Name
Tallaght University Hospital
Department Name
Oncology
Principal Investigator Name
Lynda CORRIGAN
Principal Investigator Email
lynda.corrigan@tuh.ie
Contact Person Name
Lynda CORRIGAN
Contact Person Email
lynda.corrigan@tuh.ie
Site Name
Mater Private Hospital
Department Name
Oncology
Principal Investigator Name
Daniel CAGNEY
Principal Investigator Email
Daniel.Cagney@materprivate.ie
Contact Person Name
Daniel CAGNEY
Contact Person Email
Daniel.Cagney@materprivate.ie

Spain

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
175
Number Of Sites
9
Number Of Participants
50

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Principal Investigator Name
Enrique GALLARDO DIAZ
Principal Investigator Email
egallardo@tauli.cat
Contact Person Name
Enrique GALLARDO DIAZ
Contact Person Email
egallardo@tauli.cat
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Principal Investigator Name
Juan Francisco RODRIGUEZ MORENO
Principal Investigator Email
jfrodriguez@hmhospitales.com
Contact Person Name
Juan Francisco RODRIGUEZ MORENO
Contact Person Email
jfrodriguez@hmhospitales.com
Site Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name
Oncology
Principal Investigator Name
Xavier MALDONADO PIJOAN
Principal Investigator Email
xavier.maldonado@vallhebron.cat
Contact Person Name
Xavier MALDONADO PIJOAN
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Jose JUAN FITA
Principal Investigator Email
mjjuan@fivo.org
Contact Person Name
Jose JUAN FITA
Contact Person Email
mjjuan@fivo.org
Site Name
Hospital Universitario De Badajoz
Department Name
Oncology
Principal Investigator Name
Marta GONZALEZ CORDERO
Principal Investigator Email
marta.gonzalezc@salud-juntaex.es
Contact Person Name
Marta GONZALEZ CORDERO
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Daniel Ernesto CASTELLANO
Principal Investigator Email
cdanicas@hotmail.com
Contact Person Name
Daniel Ernesto CASTELLANO
Contact Person Email
cdanicas@hotmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Oncology
Principal Investigator Name
Raquel LUQUE CARO
Principal Investigator Email
rluquecaro@gmail.com
Contact Person Name
Raquel LUQUE CARO
Contact Person Email
rluquecaro@gmail.com
Site Name
Hospital Universitario de Donostia
Department Name
Oncology
Principal Investigator Name
Amaia HERNANDEZ JORGE
Principal Investigator Email
ahernandez@onkologikoa.org
Contact Person Name
Amaia HERNANDEZ JORGE
Contact Person Email
ahernandez@onkologikoa.org
Site Name
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Department Name
Oncology
Principal Investigator Name
Ana MEDINA COLMENERO
Principal Investigator Email
ana.medina@cog.es
Contact Person Name
Ana MEDINA COLMENERO
Contact Person Email
ana.medina@cog.es

Sponsor

Primary sponsor

Full Name
Unicancer
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
NUBEQA 300 mg film-coated tablets
Active Substance
DAROLUTAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (EU/1/20/1432/001)
Maximum Dose
1200 mg
Investigational Product Name
BAY 1841788
Active Substance
DAROLUTAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
1200 mg
Investigational Product Name
LEUPRORELIN ACETATE
Active Substance
LEUPRORELIN ACETATE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Maximum Dose
22.5 mg
Investigational Product Name
TRIPTORELIN
Active Substance
TRIPTORELIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAMUSCULAR OR SUBCUTANEOUS
Route
INTRAMUSCULAR OR SUBCUTANEOUS
Maximum Dose
11.25 mg
Investigational Product Name
DEGARELIX
Active Substance
DEGARELIX
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Maximum Dose
240 mg
Investigational Product Name
GOSERELIN
Active Substance
GOSERELIN
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
10.8 mg
Combination Treatment
Yes

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