Actively Recruiting
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
Led by Zenith Epigenetics · Updated on 2026-05-08
200
Participants Needed
31
Research Sites
298 weeks
Total Duration
On this page
Sponsors
Z
Zenith Epigenetics
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Metastatic, castration-resistant, histologically confirmed prostate cancer
- Surgical or continuous medical castration for at least 8 weeks before screening with serum testosterone under 50 ng/dL confirmed within 4 weeks before first study drug dose
- Disease progression on prior abiraterone treatment by PCWG3 criteria
- Not a candidate for chemotherapy or declined chemotherapy
- For Cohort A: Poor response to abiraterone defined by less than 12 months use or failure to achieve PSA nadir of 0.2 ng/mL in hormone-sensitive setting, or less than 6 months use or failure to achieve PSA50 response in castration-resistant setting
- For Cohort B: Response to abiraterone defined by 12 months or more use with PSA nadir under 0.2 ng/mL in hormone-sensitive setting, or 6 months or more use with confirmed PSA50 response in castration-resistant setting
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- History of brain metastases, seizures, or conditions that increase seizure risk
- Previous treatment with investigational BET inhibitors including ZEN003694
- Prior use of second-generation androgen receptor inhibitors like enzalutamide, apalutamide, darolutamide, or proxalutamide
- Prior chemotherapy in metastatic castration-resistant setting (chemotherapy in hormone-sensitive setting allowed if last dose was at least 6 months before study drug)
- Systemic anti-cancer therapy within 2 weeks or five half-lives before first study drug dose
- Use of testosterone therapy after stopping abiraterone
- Unresolved toxicities related to prior systemic therapy worse than Grade 1 (except alopecia or neuropathy)
- Radiation therapy within 2 weeks before first study drug dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
California Research Institute
Los Angeles, California, United States, 90027
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
3
Innovative Clinical Research Institute
Whittier, California, United States, 90603
Actively Recruiting
4
Colorado Urology
Lakewood, Colorado, United States, 80228
Actively Recruiting
5
D&H Cancer Research Center, LLC
Margate, Florida, United States, 33063
Actively Recruiting
6
BRCR Global
Plantation, Florida, United States, 33322
Actively Recruiting
7
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States, 70809
Withdrawn
8
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
Actively Recruiting
9
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States, 10065
Completed
11
Messino Cancer Center
Asheville, North Carolina, United States, 28806
Actively Recruiting
12
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97223
Actively Recruiting
13
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Actively Recruiting
14
Texas Oncology - Central South
Austin, Texas, United States, 78731
Actively Recruiting
15
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
16
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Actively Recruiting
17
Anhui Provincial Hospital
Hefei, Anhui, China, 230002
Actively Recruiting
18
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
19
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
20
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
21
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
22
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
23
Hunan Cancer Hospital
Changsha, Hunan, China, 410006
Actively Recruiting
24
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
25
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110042
Withdrawn
26
The First Affiliated Hospital of Xi'an Jiaotang University
Xi'an, Shaanxi, China, 71000
Actively Recruiting
27
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
28
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200072
Actively Recruiting
29
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
30
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
31
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
Research Team
Z
Zenith Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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