SAKK 08/23: Addition of Darolutamide to first line treatment of mCRPC: a randomized open label phase II trial
Key facts
- Where
- Barakaldo, Barcelona, Cáceres, Castello De La Plana, Córdoba, Lugo, Madrid, Oviedo, Palma, Pamplona, Sabadell, Salamanca, San Sebastián de los Reyes, Sevilla, Toledo, Valencia és Valladolid, SpanyolországSee the 20 sites
- Phase
- 2. fázis
Where in Spanyolország
- Hospital Universitario de CrucesBarakaldo, SpanyolországTaking people
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital del MarBarcelona, SpanyolországTaking people
- Hospital San Pedro De AlcántaraCáceres, SpanyolországTaking people
- Consorcio Hospitalario Provincial De CastellonCastello De La Plana, SpanyolországTaking people
- Hospital Universitario Reina SofiaCórdoba, SpanyolországTaking people
- Hospital Universitario Lucus AugustiLugo, SpanyolországTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországTaking people
- Hospital Universitario HM SanchinarroMadrid, SpanyolországTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMadrid, SpanyolországTaking people
- Hospital Universitario Central De AsturiasOviedo, SpanyolországTaking people
- University Hospital Son EspasesPalma, SpanyolországTaking people
- Hospital Universitario de NavarraPamplona, SpanyolországTaking people
- Parc Tauli Hospital UniversitariSabadell, SpanyolországTaking people
- Hospital Universitario De SalamancaSalamanca, SpanyolországTaking people
- Hospital Universitario Infanta SofiaSan Sebastián de los Reyes, SpanyolországTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországTaking people
- Hospital Universitario de ToledoToledo, SpanyolországTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországTaking people
- Hospital Clínico Universitario de ValladolidValladolid, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Swiss Group for Clinical Cancer Research
- Trial code
- EU 2024-512132-29-00
- Record updated
- 2026. június 12.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; Presence of a small cell component; Clinical or radiological evidence of current spinal cord compression.