Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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

Trial Details

NCT ID
NCT06401980
Phase
PHASE2
Sponsor
Swiss Cancer Institute
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Darolutamide
  • Standard of care
Locations (sample)
  • Aarau, Switzerland|47.39254,8.04422
  • Baden, Switzerland|47.47333,8.30592
  • Bellinzona, Switzerland|46.19278,9.01703
  • Bern, Switzerland|46.94809,7.44744
  • Chur, Switzerland|46.84986,9.53287

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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