NCT04986423 ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
| NCT ID | NCT04986423 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zenith Epigenetics |
| Condition | Metastatic Castration-Resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-09-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2021-09-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. Males age ≥ 18 years 2. Metastatic, castration-resistant, histologically confirmed prostate cancer 3. Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone \< 50 ng/dL confirmed within 4 weeks of first administration of study drug 4. Have progressed on prior abiraterone treatment by PCWG3 criteria 5. Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy 6. Cohort A only - Patient must meet definition of poor responder to abiraterone by one of the following: 1. 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 2. Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone or failure to achieve a PSA50 response 7. Cohort B only - Patient must meet definition of responder to abiraterone by one of the following: 1. Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA \< 0.2 ng/mL 2. Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and PSA50 response 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: 1. Any history of brain metastases, prior seizure, conditions predisposing to seizure activity 2. Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694) 3. Receipt of prior second-generation androgen receptor inhibitors (e.g. enzalutamide, apalutamide, darolutamide, proxalutamide). Receipt of first-generation AR antagonists (e.g. bicalutamide, nilutamide, flutamide) does not count towards this limit. 4. Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to first dose of study drug) 5. Have received prior systemic anti-cancer therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug 6. Have received exogenous administration of testosterone therapy since discontinuation of abiraterone. 7. Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry 8. Radiation therapy within 2 weeks of the first administration of study drug
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04986423 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration-Resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04986423 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04986423 currently recruiting?
Yes, NCT04986423 is actively recruiting participants. Contact the research team at ZEN003694-201@zenithepigenetics.com for enrollment information.
Where is the NCT04986423 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Whittier, United States, Lakewood, United States and 11 additional locations.
Who is sponsoring the NCT04986423 clinical trial?
NCT04986423 is sponsored by Zenith Epigenetics. The trial plans to enroll 200 participants.
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