ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer (NCT04986423)
A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: California Research Institute — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (31 Sites)
Showing the first 25 of 31 sites.
- California Research Institute — Los Angeles, California
- University of California, San Francisco — San Francisco, California
- Innovative Clinical Research Institute — Whittier, California
- Colorado Urology — Lakewood, Colorado
- D&H Cancer Research Center, LLC — Margate, Florida
- BRCR Global — Plantation, Florida
- Hematology Oncology Clinic — Baton Rouge, Louisiana
- Maryland Oncology Hematology, P.A. — Columbia, Maryland
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
- Weill Cornell Medical College - New York Presbyterian Hospital — New York, New York
- Messino Cancer Center — Asheville, North Carolina
- Northwest Cancer Specialists, P.C. — Portland, Oregon
- Urology Associates, P.C. — Nashville, Tennessee
- Texas Oncology - Central South — Austin, Texas
- Virginia Cancer Specialists — Fairfax, Virginia
- Seattle Cancer Care Alliance — Seattle, Washington
- Anhui Provincial Hospital — Hefei, Anhui
- Chongqing Cancer Hospital — Chongqing, Chongqing Municipality
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian
- Henan Cancer Hospital — Zhengzhou, Henan
- Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology — Wuhan, Hubei
- Hubei Cancer Hospital — Wuhan, Hubei
- Hunan Cancer Hospital — Changsha, Hunan
- Nanjing Drum Tower Hospital — Nanjing, Jiangsu
- Liaoning Cancer Hospital — Shenyang, Liaoning
📞 Contact the Study Coordinator
Phone: (587) 390-7865
Email: ZEN003694-201@zenithepigenetics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Castration-Resistant Prostate Cancer
- A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer — San Francisco, California
- Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment — Tucson, Arizona
- ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC — Sacramento, California
- FPI-2265 (225Ac-PSMA-I&T) for Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) — Duarte, California
- A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer — Duarte, California
- FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer — San Francisco, California
Explore by condition: All Metastatic Castration-Resistant Prostate Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.