Actively Recruiting
Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Led by Swiss Cancer Institute · Updated on 2026-03-30
162
Participants Needed
13
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent according to Swiss law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures
- 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
- Measurable disease or bone lesions evaluable according to PCWG3 criteria
- Minimum of 12 months on ADT plus ARPI therapy within mHSPC setting, showing at least 50% PSA response or partial remission per RECIST v1.1
- Progressive disease before registration defined by at least 2 of 3: PSA progression ≥ 25% above nadir, new metastatic lesion(s) on imaging, or clinical progression
- Patients with prior malignancy allowed if risk of interference is very low
- Age 18 years or older
- WHO performance status 0-2
- Adequate bone marrow, liver, and kidney function per specified laboratory values
- Men agree not to donate sperm or father a child during treatment and for 3 months after
- Ability and willingness to swallow darolutamide tablets whole
You will not qualify if you...
- 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
- Treatment with other experimental drugs within 28 days before registration
- Use of other anti-cancer drugs or radiotherapy except for local pain control and GnRH analogues
- Severe or uncontrolled cardiovascular disease
- Recent acute exacerbations of chronic illnesses, serious infections, or major surgery within 28 days before treatment
- Clinical or radiological evidence of current spinal cord compression
- Use of drugs contraindicated with darolutamide
- Known hypersensitivity to darolutamide
- Gastrointestinal disease or procedure that could affect darolutamide absorption or tolerance
- Any serious medical, psychiatric, psychological, familial, or geographical condition that may interfere with treatment or follow-up
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Tumorzentrum Aarau TZA
Aarau, Switzerland, 5000
Actively Recruiting
2
Kantonsspital Baden
Baden, Switzerland, 5404
Actively Recruiting
3
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, Switzerland, 6500
Actively Recruiting
4
Inselspital
Bern, Switzerland
Actively Recruiting
5
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Actively Recruiting
6
Hôpitaux Universitaires Genève HUG
Geneva, Switzerland, 1211
Actively Recruiting
7
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland, CH-1011
Actively Recruiting
8
Luzerner Kantonsspital
Lucerne, Switzerland, 6004
Actively Recruiting
9
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
10
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Actively Recruiting
11
OnkoZentrum Zürich - Standort Seefeld
Zurich, Switzerland, 8038
Actively Recruiting
12
Stadtspital Triemli Zürich
Zurich, Switzerland, 8063
Actively Recruiting
13
UniversitaetsSpital Zuerich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
S
Simone Rahel Wyss-Neyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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