Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Despite improvements in treatment, metastatic prostate cancer remains incurable, especially in the case of pretreated metastatic castration-resistant disease (mCRPC), where treatment options are limited, leading to an unmet need. The paradigm shift in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has affected the treatment landscape for mCRPC patients. Many have already received androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI), making first-line mCRPC treatment challenging. The Swiss Group for Clinical Cancer Research (SAKK) has shown in previous studies that maintenance treatment with an ARPI, such as darolutamide, can improve radiographic progression-free survival (rPFS) in pretreated mCRPC patients. In the SAKK 08/16 trial, darolutamide maintenance was found to prolong PFS compared to placebo, especially in patients who responded well to prior ARPI treatment. Based on these findings, the hypothesis is that continued AR-pathway blockade with darolutamide, initiated in patients progressing from mHSPC to mCRPC on ARPI treatment, can improve outcomes when added to standard first-line mCRPC therapy and continued as maintenance. The proposed study aims to evaluate the efficacy of darolutamide, combined with physician-choice standard of care (including taxane chemotherapy, olaparib, radium 223, or LuPSMA), followed by maintenance therapy, on rPFS for patients in the first-line setting of mCRPC.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjent świadomie zgadza się na udział w badaniu i wszystkie procedury z nim związane.
- •Potwierdzony rak prostaty (gruczolak)
- •Rak prostaty jest oporny na kastrację (nie reaguje na leczenie obniżające hormony męskie lub po kastracji chirurgicznej).
- •Rak rozsiany w ciele, potwierdzony badaniami obrazowymi.
- •Rak prostaty postępował mimo co najmniej 12 miesięcy leczenia hormonami i innymi lekami (ADT+ARPI).
- •Choroba postępowała (np. wzrost PSA, nowe zmiany na obrazach, pogorszenie stanu ogólnego).
- •Pacjent czuje się na tyle dobrze, by wziąć udział w badaniu (stan sprawności wg skali WHO 0-2).
- •Wiek powyżej 18 lat.
✗ Disqualifies
- •Inne nowotwory w przeszłości, które mogą wpływać na bezpieczeństwo lub wyniki badania.
- •Problemy z krwią, wątrobą lub nerkami, które są zbyt poważne.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 1, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (13)
Tumorzentrum Aarau TZA
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, Switzerland
Inselspital
Bern, Switzerland
Kantonsspital Graubuenden
Chur, Switzerland
Hôpitaux Universitaires Genève HUG
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
OnkoZentrum Zürich - Standort Seefeld
Zurich, Switzerland
Stadtspital Triemli Zürich
Zurich, Switzerland
UniversitaetsSpital Zuerich
Zurich, Switzerland
Trial contact
Stefanie Röthlisberger Röthlisberger, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.