2024-512132-29-00RecruitingPhase 2
SAKK 08/23: Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 18 Feb 2025
- Start date
- 6 Aug 2025
- Lead sponsor
- Swiss Group for Clinical Cancer Research
- Diseases
- Prostate cancer
- EU CT number
- 2024-512132-29-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. They have not yet had treatment for this stage. It tests adding darolutamide to standard care.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma that has spread (metastatic) and keeps growing despite castration (mCRPC); spread shown on imaging
- Earlier treatment
- Must have responded to an ARPI for at least 12 months in the hormone-sensitive stage. Must stay on GnRH analogues during the trial unless surgically castrated. Must not have had other systemic treatment for the castration-resistant stage.
Main reasons for not taking part
- A small cell component in the tumour
- Prior LuPSMA or radium 223 for prostate cancer
- Prior chemotherapy for the hormone-sensitive stage, except docetaxel
- Severe or uncontrolled heart or blood vessel disease
- Current spinal cord compression
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Any concomitant drugs contraindicated for use with darolutamide or known hypersensitivity to darolutamide.
Other illness
- 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.
- Severe or uncontrolled cardiovascular disease.
- Acute exacerbations of chronic illnesses, serious infections, or major surgery before start of treatment.
Other
- Presence of a small cell component.
- Clinical or radiological evidence of current spinal cord compression.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Cruces | Barakaldo | Spain | Recruiting |
| Hospital del Mar | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital San Pedro De Alcántara | Cáceres | Spain | Recruiting |
| Consorcio Hospitalario Provincial De Castellon | Castello De La Plana | Spain | Recruiting |
| Hospital Universitario Reina Sofia | Córdoba | Spain | Recruiting |
| Hospital Universitario Lucus Augusti | Lugo | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro | Madrid | Spain | Recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Recruiting |
| University Hospital Son Espases | Palma | Spain | Recruiting |
| Hospital Universitario de Navarra | Pamplona | Spain | Recruiting |
| Parc Tauli Hospital Universitari | Sabadell | Spain | Recruiting |
| Hospital Universitario De Salamanca | Salamanca | Spain | Recruiting |
| Hospital Universitario Infanta Sofia | San Sebastián de los Reyes | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Recruiting |
| Hospital Universitario de Toledo | Toledo | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid | Valladolid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.