ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer

This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior abiraterone by PCWG3 criteria. Disease must have progressed on only abiraterone by PCWG3 criteria prior to study entry. The patient population will be separated into two cohorts: Cohort A: Patients with poor response to prior abiraterone defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: \< 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while

Trial Details

NCT ID
NCT04986423
Phase
PHASE2
Sponsor
Zenith Epigenetics
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • ZEN003694
  • Enzalutamide
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Whittier, California, United States|33.97918,-118.03284
  • Lakewood, Colorado, United States|39.70471,-105.08137
  • Margate, Florida, United States|26.24453,-80.20644

Key Eligibility Criteria

  • Males age ≥ 18 years
  • Metastatic, castration-resistant, histologically confirmed prostate cancer
  • Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone \< 50 ng/dL confirmed within 4 weeks of f…
  • Have progressed on prior abiraterone treatment by PCWG3 criteria

For full eligibility, visit ClinicalTrials.gov.

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