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Study identifier: NCT04986423 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Metastatic Castration-Resistant Prostate Cancer  ·  Sponsor: Zenith Epigenetics

PhasePhase 2
Planned participants200
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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 taking abiraterone, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone or failure to achieve PSA50 response while on abiraterone Cohort B: Patients with response to prior abiraterone, defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA \< 0.2 ng/mL, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and confirmed PSA50 response

This description comes directly from the study's public registry record.

Talk to the study team

Zenith Study Team  ·  587-390-7865  ·  ZEN003694-201@zenithepigenetics.com

Always discuss trial participation with your own doctor first.

Locations (31)

California Research InstituteLos Angeles, California, United StatesRecruiting
University of California, San FranciscoSan Francisco, California, United StatesRecruiting
Innovative Clinical Research InstituteWhittier, California, United StatesRecruiting
Colorado UrologyLakewood, Colorado, United StatesRecruiting
D&H Cancer Research Center, LLCMargate, Florida, United StatesRecruiting
BRCR GlobalPlantation, Florida, United StatesRecruiting
Hematology Oncology ClinicBaton Rouge, Louisiana, United StatesWithdrawn
Maryland Oncology Hematology, P.A.Columbia, Maryland, United StatesRecruiting
University of Michigan Rogel Cancer CenterAnn Arbor, Michigan, United StatesRecruiting
Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United StatesCompleted
Messino Cancer CenterAsheville, North Carolina, United StatesRecruiting
Northwest Cancer Specialists, P.C.Portland, Oregon, United StatesRecruiting

+ 19 more locations — full list on the registry record.

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