Clinical trial • Phase II • Oncology

DAROLUTAMIDE for Metastatic castration-resistant prostate cancer

Phase II trial of DAROLUTAMIDE for Metastatic castration-resistant prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer
Trial Stage
Phase II
Drug Modality
Small molecule | Radiopharmaceutical

Key dates

Initial CTIS Submission Date
18-02-2025
First CTIS Authorization Date
22-05-2025

Trial design

Randomised, open-label, darolutamide (bay 1841788) added to physician-choice standard of care versus physician-choice standard of care alone; specific doses and schedules are not specified in the available documents.-controlled Phase II trial in Spain, Switzerland.

Randomised
Yes
Open Label
Yes
Comparator
Darolutamide (BAY 1841788) added to physician-choice standard of care versus physician-choice standard of care alone; specific doses and schedules are not specified in the available documents.
Target Sample Size
100

Eligibility

Recruits 100 No vulnerable population selected; participants are adult male patients. Informed consent is required from participants; no assent or parental consent procedures for minors are described in the available materials..

Vulnerable Population
No vulnerable population selected; participants are adult male patients. Informed consent is required from participants; no assent or parental consent procedures for minors are described in the available materials.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.\n- Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)\n- Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial\n- Metastatic disease, documented by imaging according to PCWG3 criteria\n- Prior response to ARPI for at least 12 months in the mHSPC setting.\n- Adequate bone marrow, hepatic and renal functions."}

Exclusion criteria

  • {"criterion_text":"- Presence of a small cell component.\n- Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of darolutamide.\n- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.\n- Prior systemic therapy for metastatic castration-resistant disease.\n- Prior chemotherapy for mHSPC, except docetaxel.\n- Prior LuPSMA or radium 223 for prostate cancer.\n- Concomitant use of other anti-cancer drugs or radiotherapy except for local pain control and GnRH analogues.\n- Severe or uncontrolled cardiovascular disease.\n- Acute exacerbations of chronic illnesses, serious infections, or major surgery before start of treatment.\n- Clinical or radiological evidence of current spinal cord compression.\n- Any concomitant drugs contraindicated for use with darolutamide or known hypersensitivity to darolutamide."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Radiographic progression-free survival.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to symptomatic/clinical progression.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to PSA progression (defined according to PCWG3).","definition_or_measurement_approach":"Defined according to PCWG3"}
  • {"endpoint_text":"- Event-free survival (EFS) – event being defined as one of the following: - death from any cause - presence of radiographic progression and symptomatic/clinical progression; - presence of radiographic progression and PSA progression; - presence of symptomatic/clinical progression and PSA progression","definition_or_measurement_approach":"Event defined as any of: death from any cause; presence of radiographic progression and symptomatic/clinical progression; presence of radiographic progression and PSA progression; presence of symptomatic/clinical progression and PSA progression"}
  • {"endpoint_text":"- Objective response rate according to RECIST.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PSA response (30%, 50%, 90% and best).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of PSA response (50%).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- AEs.","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
True, Grupo Espanol De Oncologia Genitourinaria-Socug | Swiss Group for Clinical Cancer Research
Planned Sample Size
100
Recruitment Window Months
61
Consent Approach
Informed consent is required from participants. Subject information and informed consent form documents are listed (general and pregnant partner versions and translated/TC versions). No assent or minor/parental consent procedures are described in the available materials.

Geography

Total Number Of Sites
20
Total Number Of Participants
162

Spain

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
340
Number Of Sites
20
Number Of Participants
100

Sites

Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
oncology
Principal Investigator Name
Aránzazu González del Alba
Principal Investigator Email
aranglezalba@yahoo.es
Contact Person Name
Aránzazu González del Alba
Contact Person Email
aranglezalba@yahoo.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
oncology
Principal Investigator Name
Begoña Pérez Valderrama
Principal Investigator Email
bpvalderrama@gmail.com
Contact Person Name
Begoña Pérez Valderrama
Contact Person Email
bpvalderrama@gmail.com
Site Name
Consorcio Hospitalario Provincial De Castellon
Department Name
oncology
Principal Investigator Name
Alfredo Sánchez Hernández
Principal Investigator Email
asanchezh@seom.org
Contact Person Name
Alfredo Sánchez Hernández
Contact Person Email
asanchezh@seom.org
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
oncology
Principal Investigator Name
Ricardo Sánchez Escribano
Principal Investigator Email
rsescribano@seom.org
Contact Person Name
Ricardo Sánchez Escribano
Contact Person Email
rsescribano@seom.org
Site Name
Hospital Universitario De Toledo
Department Name
oncology
Principal Investigator Name
Icíar García Carbonero
Principal Investigator Email
igcarbonero@yahoo.es
Contact Person Name
Icíar García Carbonero
Contact Person Email
igcarbonero@yahoo.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
oncology
Principal Investigator Name
Regina Gironés Sarrió
Principal Investigator Email
girones_reg@gva.es
Contact Person Name
Regina Gironés Sarrió
Contact Person Email
girones_reg@gva.es
Site Name
Hospital Clinic De Barcelona
Department Name
oncology
Principal Investigator Name
Begoña Mellado
Principal Investigator Email
BMELLADO@clinic.cat
Contact Person Name
Begoña Mellado
Contact Person Email
BMELLADO@clinic.cat
Site Name
University Hospital Son Espases
Department Name
oncology
Principal Investigator Name
Marina Justo de la Peña
Principal Investigator Email
marina.justo@ssib.es
Contact Person Name
Marina Justo de la Peña
Contact Person Email
marina.justo@ssib.es
Site Name
Hospital Universitario Central De Asturias
Department Name
oncology
Principal Investigator Name
Carlos Álvarez Fernández
Principal Investigator Email
carlos.alvfer@gmail.com
Contact Person Name
Carlos Álvarez Fernández
Contact Person Email
carlos.alvfer@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
oncology
Principal Investigator Name
María José Méndez
Principal Investigator Email
mjosemv@yahoo.es
Contact Person Name
María José Méndez
Contact Person Email
mjosemv@yahoo.es
Site Name
Hospital Del Mar
Department Name
oncology
Principal Investigator Name
Alejo Rodríguez-Vida
Principal Investigator Email
arodriguezvida@parcdesalutmar.cat
Contact Person Name
Alejo Rodríguez-Vida
Site Name
Hospital San Pedro De Alcantara
Department Name
oncology
Principal Investigator Name
Ricardo Collado Martín
Principal Investigator Email
porcupaintri1@yahoo.es
Contact Person Name
Ricardo Collado Martín
Contact Person Email
porcupaintri1@yahoo.es
Site Name
Parc Tauli Hospital Universitari
Department Name
oncology
Principal Investigator Name
Enrique Gallardo
Principal Investigator Email
egallardo@tauli.cat
Contact Person Name
Enrique Gallardo
Contact Person Email
egallardo@tauli.cat
Site Name
Hospital Universitario Lucus Augusti
Department Name
oncology
Principal Investigator Name
Sergio Vázquez Estévez
Principal Investigator Email
Sergio.Vazquez.Estevez@sergas.es
Contact Person Name
Sergio Vázquez Estévez
Site Name
Hospital Universitario De Navarra
Department Name
oncology
Principal Investigator Name
Nuria Lainez Milagro
Principal Investigator Email
nuria.lainez.milagro@navarra.es
Contact Person Name
Nuria Lainez Milagro
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
oncology
Principal Investigator Name
Imanol Martínez Salas
Principal Investigator Email
imanol.martinez@quironsalud.es
Contact Person Name
Imanol Martínez Salas
Contact Person Email
imanol.martinez@quironsalud.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
oncology
Principal Investigator Name
Juan Francisco Rodríguez Moreno
Principal Investigator Email
jfrodriguez@hmhospitales.com
Contact Person Name
Juan Francisco Rodríguez Moreno
Contact Person Email
jfrodriguez@hmhospitales.com
Site Name
Hospital Universitario De Salamanca
Department Name
oncology
Principal Investigator Name
Rebeca Lozano Mejorada
Principal Investigator Email
rebecalozano@saludcastillayleon.es
Contact Person Name
Rebeca Lozano Mejorada
Site Name
Hospital Universitario De Cruces
Department Name
oncology
Principal Investigator Name
Ricardo Fernández Rodríguez
Principal Investigator Email
ricardo.rfr64@gmail.com
Contact Person Name
Ricardo Fernández Rodríguez
Contact Person Email
ricardo.rfr64@gmail.com
Site Name
Hospital Universitario Infanta Sofía
Department Name
oncology
Principal Investigator Name
Francisco Zambrana
Principal Investigator Email
currozambrana@gmail.com
Contact Person Name
Francisco Zambrana
Contact Person Email
currozambrana@gmail.com

Switzerland

Latest Decision Or Authorization Date
22-05-2025
Number Of Participants
62

Sponsor

Primary sponsor

Full Name
Swiss Group for Clinical Cancer Research
Organisation Type
Patient organisation/association
Country Of Registered Address
Switzerland

Third parties

  • {"country":"Spain","full_name":"Grupo Espanol De Oncologia Genitourinaria-Socug","duties_or_roles":"codes: 2,5","organisation_type":"Patient organisation/association"}
  • {"country":"Spain","full_name":"Evidenze Health Espana S.L.","duties_or_roles":"codes: 1,12","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BAY 1841788
Active Substance
DAROLUTAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational (prodAuthStatus=1)
Maximum Dose
1200 mg
Investigational Product Name
Lutathera 370 MBq/mL solution for infusion
Active Substance
LUTETIUM (177LU) OXODOTREOTIDE
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (prodAuthStatus=2)
Maximum Dose
7400 MBq
Investigational Product Name
Xofigo 1100 kBq/mL solution for injection
Active Substance
RADIUM RA 223 DICHLORIDE
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus=2)
Maximum Dose
25 mg/m2
Investigational Product Name
Lynparza 150 mg film-coated tablets
Active Substance
OLAPARIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus=2)
Maximum Dose
600 mg
Investigational Product Name
Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion
Active Substance
CABAZITAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (prodAuthStatus=2)
Maximum Dose
25 mg/m2
Investigational Product Name
Docetaxel Aurovitas 20 mg/ml concentrado para solución para perfusión
Active Substance
DOCETAXEL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (prodAuthStatus=2)
Maximum Dose
25 mg/m2
Combination Treatment
Yes

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