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
Hormone-Sensitive 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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