Metastatic Castration-Resistant Prostate CancerPhase 2NCT04986423
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study testing ZEN003694 and Enzalutamide in people with Metastatic Castration-Resistant Prostate Cancer, run by Zenith Epigenetics at 31 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- ZEN003694 and Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 8 Sep 2021to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 first administration of study drug
- Have progressed on prior abiraterone treatment by PCWG3 criteria
- Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy
- Cohort A only - Patient must meet definition of poor responder to abiraterone by one of the following:
Show all 12Show fewer
- 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
- Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: < 6 months duration on abiraterone or failure to achieve a PSA50 response
- Cohort B only - Patient must meet definition of responder to abiraterone by one of the following:
- Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA < 0.2 ng/mL
- Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and PSA50 response
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- Any history of brain metastases, prior seizure, conditions predisposing to seizure activity
- Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694)
- 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.
- 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)
- 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
- Have received exogenous administration of testosterone therapy since discontinuation of abiraterone.
- Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
- Radiation therapy within 2 weeks of the first administration of study drug
Trial locations and contacts
31 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 2 countries
United States16 sites, 14 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
- Recruiting
Messino Cancer Center
Asheville, North Carolina, 28806
- Recruiting
Texas Oncology - Central South
Austin, Texas, 78731
- Withdrawn
Hematology Oncology Clinic
Baton Rouge, Louisiana, 70809
- Recruiting
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
Colorado Urology
Lakewood, Colorado, 80228
- Recruiting
California Research Institute
Los Angeles, California, 90027
- Recruiting
D&H Cancer Research Center, LLC
Margate, Florida, 33063
- Recruiting
Urology Associates, P.C.
Nashville, Tennessee, 37209
- Completed
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10065
- Recruiting
BRCR Global
Plantation, Florida, 33322
- Recruiting
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97223
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
- Recruiting
Seattle Cancer Care Alliance
Seattle, Washington, 98109
- Recruiting
Innovative Clinical Research Institute
Whittier, California, 90603
China15 sites, 14 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410006
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230002
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
- Withdrawn
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
- Recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotang University
Xi'an, Shaanxi, 71000
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With 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:
Read more
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
- Being tested
- ZEN003694, Enzalutamide
- Keywords
- mCRPC, ZEN003694, ZEN-3694, Bromodomain, BETi, Enzalutamide, Xtandi®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEN003694Drug
Also called ZEN-3694
72 mg PO QD
EnzalutamideDrug
Also called Xtandi®, MDV3100
160 mg PO QD
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - ZEN003694 + Enzalutamide | Experimental | Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles. Receives: Drug: ZEN003694; Drug: Enzalutamide |
| Cohort A - Enzalutamide | Active comparator | Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review. Receives: Drug: Enzalutamide |
| Cohort B - ZEN003694 + Enzalutamide | Experimental | Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles. Receives: Drug: ZEN003694; Drug: Enzalutamide |
| Cohort B - Enzalutamide | Active comparator | Patients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review. Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A: Radiographic progression-free survival (rPFS) by BICR
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Measured: Randomization up to 30 months
Secondary outcomes (17)
Cohorts A + B: Radiographic progression-free survival (rPFS) by BICR
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3
Measured: Randomization up to 30 months
Cohort A: Radiographic progression-free survival (rPFS) by investigator assessment
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Measured: Randomization up to 30 months
Cohort A + B: Radiographic progression-free survival (rPFS) by investigator assessment
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
Measured: Randomization up to 30 months
Cohort A: Progression-free survival (PFS) by investigator assessment
Time from date of randomization to the date of first disease radiographic progression, clinical progression, or death for any reason. Radiographic progression of disease will be evaluated by RECIST 1.1 and PCWG3 by investigator assessment. Clinical progression is significant pain increase or clinical deterioration that requires initiating another line of treatment.
Measured: Randomization up to 30 months
Cohort A + B: Progression-free survival (PFS) by investigator assessment
Time from date of randomization to the date of first disease radiographic progression, clinical progression, or death for any reason. Radiographic progression of disease will be evaluated by RECIST 1.1 and PCWG3 by investigator assessment. Clinical progression is significant pain increase or clinical deterioration that requires initiating another line of treatment.
Measured: Randomization up to 30 months
Cohort A: Overall survival (OS)
Time from date of randomization to the date of death from any cause
Measured: Randomization up to 30 months
Cohort A + B: Overall survival (OS)
Time from date of randomization to the date of death from any cause
Measured: Randomization up to 30 months
Cohort A: PSA50 response rate
PSA response is a reduction in serum PSA concentration of ≥50% from baseline.
Measured: Randomization up to 30 months
Cohort A + B: PSA50 response rate
PSA response is a reduction in serum PSA concentration of ≥50% from baseline.
Measured: Randomization up to 30 months
Cohort A: Assess efficacy endpoints for patients enrolled in the USA
Measured: Randomization up to 30 months
Cohort A + B: Assess efficacy endpoints for patients enrolled in the USA
Measured: Randomization up to 30 months
Objective response rate (ORR)
Proportion of the patients who have either a complete response (CR) or partial response (PR) by RECIST 1.1 criteria who have measurable disease at baseline.
Measured: Randomization up to 30 months
Patient-reported health status and quality of life (QoL) measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on a 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Measured: Screening and Day 1 of every 28-day Cycle up to 30 months
Patient-reported health status and quality of life (QoL) measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Module (EORTC QLQ-PR25).
EORTC QLQ-PR25: prostate cancer specific instrument with 25 questions used in conjunction with EORTC QLQ-C30 to assess the participant QoL. Used to evaluate 5 multi-item scales (urinary, bowel, and hormonal treatment-related symptoms, sexual activity, and sexual functioning) and one single item (problems due to incontinence aid use). Each question assessed on a 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.
Measured: Screening and Day 1 of every 28-day Cycle up to 30 months
Time to initiation of chemotherapy
Time from date of randomization to the first dose of chemotherapy.
Measured: Randomization up to 30 months
Time to first skeletal related event (SRE)
Time from date of randomization to the first SRE such as pathological fracture, surgery/radiotherapy for pain/prevention of fracture, hypercalcemia, and spinal cord compression.
Measured: Randomization up to 30 months
Measure plasma concentrations of ZEN003694 and the active metabolite ZEN003791
Plasma concentrations of ZEN003694 and the active metabolite ZEN003791 will be measured.
Measured: Cycle 1 Day 1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose; Cycle 2 Day1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start8 Sep 2021
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenith Epigenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc, Newsoara Biopharma Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986423
- Sponsor's protocol ID
- ZEN003694-201
- Status last verified
- May 2026
- First submitted
- 14 Jul 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04986423
- Acronym / sponsor ID
- ZEN003694-201
- Keywords
- mCRPC, ZEN003694, ZEN-3694, Bromodomain, BETi, Enzalutamide, Xtandi®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zenith EpigeneticsIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc, Newsoara Biopharma Co., Ltd.
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A - ZEN003694 + Enzalutamide | Experimental | Drug: ZEN003694, Drug: EnzalutamidePatients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles. |
| Cohort A - Enzalutamide | Active comparator | Drug: EnzalutamidePatients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review. |
| Cohort B - ZEN003694 + Enzalutamide | Experimental | Drug: ZEN003694, Drug: EnzalutamidePatients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to the initiation of the combination therapy (Lead-in) to reach steady state concentration (Css) prior to Cycle 1. After the Lead-in, ZEN003694 (72 mg) will be administered orally one daily in combination with daily enzalutamide for 28-day cycles. |
| Cohort B - Enzalutamide | Active comparator | Drug: EnzalutamidePatients will be administered enzalutamide (160 mg) orally once daily for 21 days prior to Cycle 1 Day 1 (Lead-in). After the Lead-in, patients will be administered enzalutamide 160 mg orally once daily for 28-day cycles. Active control patients will have the option to cross-over to treatment with ZEN003694 in combination with enzalutamide upon confirmed radiographic progression by PCWG3 criteria by independent central review. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 first administration of study drug
- Have progressed on prior abiraterone treatment by PCWG3 criteria
- Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy
Key exclusion criteria (8 listed)
- Any history of brain metastases, prior seizure, conditions predisposing to seizure activity
- Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694)
- 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.
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZEN003694Also: ZEN-369472 mg PO QD | Drug | Cohort A - ZEN003694 + Enzalutamide, Cohort B - ZEN003694 + Enzalutamide |
| EnzalutamideAlso: Xtandi®, MDV3100160 mg PO QD | Drug | Cohort A - Enzalutamide, Cohort A - ZEN003694 + Enzalutamide, Cohort B - Enzalutamide, Cohort B - ZEN003694 + Enzalutamide |
Primary outcome
Cohort A: Radiographic progression-free survival (rPFS) by BICR
Time frame: Randomization up to 30 months
Time from date of randomization to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated by RECIST 1.1 and PCWG3.
17 secondary outcomes
Cohorts A + B: Radiographic progression-free survival (rPFS) by BICR
Time frame: Randomization up to 30 months
Cohort A: Radiographic progression-free survival (rPFS) by investigator assessment
Time frame: Randomization up to 30 months
Cohort A + B: Radiographic progression-free survival (rPFS) by investigator assessment
Time frame: Randomization up to 30 months
Cohort A: Progression-free survival (PFS) by investigator assessment
Time frame: Randomization up to 30 months
Cohort A + B: Progression-free survival (PFS) by investigator assessment
Time frame: Randomization up to 30 months
Cohort A: Overall survival (OS)
Time frame: Randomization up to 30 months
Cohort A + B: Overall survival (OS)
Time frame: Randomization up to 30 months
Cohort A: PSA50 response rate
Time frame: Randomization up to 30 months
Cohort A + B: PSA50 response rate
Time frame: Randomization up to 30 months
Cohort A: Assess efficacy endpoints for patients enrolled in the USA
Time frame: Randomization up to 30 months
Cohort A + B: Assess efficacy endpoints for patients enrolled in the USA
Time frame: Randomization up to 30 months
Objective response rate (ORR)
Time frame: Randomization up to 30 months
Patient-reported health status and quality of life (QoL) measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Screening and Day 1 of every 28-day Cycle up to 30 months
Patient-reported health status and quality of life (QoL) measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Module (EORTC QLQ-PR25).
Time frame: Screening and Day 1 of every 28-day Cycle up to 30 months
Time to initiation of chemotherapy
Time frame: Randomization up to 30 months
Time to first skeletal related event (SRE)
Time frame: Randomization up to 30 months
Measure plasma concentrations of ZEN003694 and the active metabolite ZEN003791
Time frame: Cycle 1 Day 1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose; Cycle 2 Day1: Pre-dose, 1 hour, 2 hours, and 4 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZEN003694 and Enzalutamide in people with Metastatic Castration-Resistant Prostate Cancer, run by Zenith Epigenetics at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zenith Study Team (587-390-7865, ZEN003694-201@zenithepigenetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A: Radiographic progression-free survival (rPFS) by BICR (time frame: Randomization up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.