Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
162
Countries
1
Sites
20
Metastatic castration-resistant prostate cancer
The main objective is to assess the efficacy of darolutamide, used in addition to physician-choice standard of care and then in maintenance therapy, on radiographic progression-free survival (rPFS) for patients in the first line setting of mCRPC.
Key facts
- Sponsor
- Swiss Group for Clinical Cancer Research
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 6 Aug 2025 → ongoing
- Decision date (initial)
- 2025-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The main objective is to assess the efficacy of darolutamide, used in addition to physician-choice standard of care and then in maintenance therapy, on radiographic progression-free survival (rPFS) for patients in the first line setting of mCRPC.
Conditions and MedDRA coding
Metastatic castration-resistant prostate cancer
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-502084-38-00 | (20321) An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer sponsored studies | Bayer Consumer Care AG |
| 2022-501343-33-00 | (21492 ARASTEP) A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer | Bayer Consumer Care AG |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
- Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
- Metastatic disease, documented by imaging according to PCWG3 criteria
- Prior response to ARPI for at least 12 months in the mHSPC setting.
- Adequate bone marrow, hepatic and renal functions.
Exclusion criteria 11
- Presence of a small cell component.
- Prior systemic therapy for metastatic castration-resistant disease.
- Prior chemotherapy for mHSPC, except docetaxel.
- Prior LuPSMA or radium 223 for prostate cancer.
- Concomitant use of other anti-cancer drugs or radiotherapy except for local pain control and GnRH analogues.
- Severe or uncontrolled cardiovascular disease.
- Acute exacerbations of chronic illnesses, serious infections, or major surgery before start of treatment.
- Clinical or radiological evidence of current spinal cord compression.
- Any concomitant drugs contraindicated for use with darolutamide or known hypersensitivity to darolutamide.
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of darolutamide.
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Radiographic progression-free survival.
Secondary endpoints 8
- Overall survival.
- Time to symptomatic/clinical progression.
- Time to PSA progression (defined according to PCWG3).
- 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
- Objective response rate according to RECIST.
- PSA response (30%, 50%, 90% and best).
- Duration of PSA response (50%).
- AEs.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD1849573 · Product
- Active substance
- Darolutamide
- Other product name
- ODM-201 300 mg film-coated tablet
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 5
Lutathera 370 MBq/mL solution for infusion
PRD5434501 · Product
- Active substance
- Lutetium (177LU) Oxodotreotide
- Substance synonyms
- 177LU-DOTA-TYR3-OCTREOTATE, 177LU-DOTA0-TYR3-OCTREOTATE, 177LU-DOTATATE, DOTATATE LUTENIUM LU-177, LUTETIUM (177LU) DOTATATE, LUTETIUM (177LU)-N-[(4,7,10-TRICARBOXYMETHYL-1,4,7,10-TETRAAZACYCLODODEC-1-YL)ACETYL]-D-PHENYLALANYL-L-CYSTEINYL-L-TYROSYL-D-TRYPTOPHANYL-L-LYSYL-L-THREONINYL-L-CYSTEINYL-L-THREONINE-CYCLIC(2-7)DISULPHIDE
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 7400 MBq megabecquerel(s)
- Max total dose
- 7400 MBq megabecquerel(s)
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Authorised
- ATC code
- V10XX04 — -
- Marketing authorisation
- EU/1/17/1226/001
- MA holder
- ADVANCED ACCELERATOR APPLICATIONS
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion
PRD8294078 · Product
- Active substance
- Cabazitaxel
- Substance synonyms
- XRP6258, CABAZITAXELUM, XRP 6258
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/square meter
- Max total dose
- 25 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD04 — -
- Marketing authorisation
- EU/1/20/1448/001
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Aurovitas 20 mg/ml concentrado para solución para perfusión
PRD10213565 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 25 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- 72.635
- MA holder
- EUGIA PHARMA (MALTA) LTD
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lynparza 150 mg film-coated tablets
PRD6152224 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XK01 — -
- Marketing authorisation
- EU/1/14/959/004
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xofigo 1100 kBq/mL solution for injection
PRD3220217 · Product
- Active substance
- Radium Ra 223 Dichloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/square meter
- Max total dose
- 25 mg/m2 milligram(s)/square meter
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- V10XX03 — -
- Marketing authorisation
- EU/1/13/873/001
- MA holder
- BAYER AG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Swiss Group for Clinical Cancer Research
- Sponsor organisation
- Swiss Group for Clinical Cancer Research
- Address
- Effingerstrasse 33
- City
- Bern
- Postcode
- 3008
- Country
- Switzerland
Scientific contact point
- Organisation
- Swiss Group for Clinical Cancer Research
- Contact name
- Richard Cathomas
Public contact point
- Organisation
- Swiss Group for Clinical Cancer Research
- Contact name
- Richard Cathomas
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Grupo Espanol De Oncologia Genitourinaria-Socug ORG-100013353
|
Madrid, Spain | Code 2, Code 5 |
| Evidenze Health Espana S.L. ORG-100041907
|
Barcelona, Spain | On site monitoring, Code 12 |
Locations
1 EU/EEA country · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 100 | 20 |
| Rest of world
Switzerland
|
— | 62 | — |
Investigational sites
University Hospital Son Espases
oncology, Carretera Valldemossa 79, 07120, Palma
Hospital San Pedro De Alcantara
oncology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario Fundacion Jimenez Diaz
oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
oncology, Calle Ona 10, 28050, Madrid
Hospital Del Mar
oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario De Navarra
oncology, Irunlarrea Kalea 3, 31008, Pamplona
University Hospital Virgen Del Rocio S.L.
oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Salamanca
oncology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Clinico Universitario De Valladolid
oncology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Universitario Infanta Sofía
oncology, Paseo De Europa 34, 28702, San Sebastian De Los Reyes
Hospital Universitario Y Politecnico La Fe
oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Parc Tauli Hospital Universitari
oncology, Parc Del Tauli 1, 08208, Sabadell
Consorcio Hospitalario Provincial De Castellon
oncology, Avinguda Del Doctor Clara 19, 12006, Castello De La Plana
Hospital Universitario Lucus Augusti
oncology, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital Universitario De Cruces
oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Clinic De Barcelona
oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Central De Asturias
oncology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Puerta De Hierro De Majadahonda
oncology, Calle De San Martin De Porres 4, 28035, Madrid
Hospital Universitario De Toledo
oncology, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital Universitario Reina Sofia
oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-08-06 | 2025-08-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-512132-29-00 | 2.1 |
| Protocol (for publication) | D1_Protocol_v2_TC | 2.1 |
| Protocol (for publication) | SAKK 0823 Protocol v3 0 | 3 |
| Protocol (for publication) | SAKK 0823 Protocol v3 0 Spain tc | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General | 0.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner | 0.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TC | 0.4 |
| Subject information and informed consent form (for publication) | SAKK 0823 eligibility worksheet v3 0 | 3.0 |
| Subject information and informed consent form (for publication) | SAKK 0823 eligibility worksheet v3 0 TC | 3.0 |
| Subject information and informed consent form (for publication) | SAKK 0823 HIP CI Embarazo v0 2 19012026 cc | 0.2 |
| Subject information and informed consent form (for publication) | SAKK 0823 HIP CI Embarazo v0 2 19012026 clean | 0.2 |
| Subject information and informed consent form (for publication) | SAKK 0823 HIP CI General v0 5 19012026 cc | 0.5 |
| Subject information and informed consent form (for publication) | SAKK 0823 HIP CI General v0 5 19012026 clean | 0.5 |
| Synopsis of the protocol (for publication) | D1_ Protocol Synopsis v_ESP TC | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Spanish 2024-512132-29-00 | 2.1 |
| Synopsis of the protocol (for publication) | Sinopsis Prot v3 0 19012026 ESP clean | 3 |
| Synopsis of the protocol (for publication) | Sinopsis Prot v3 0 19012026 ESP tc | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-18 | Spain | Acceptable 2025-05-21
|
2025-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-12 | Spain | Acceptable 2026-04-21
|
2026-04-24 |