Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug cocktail aims to outsmart resistant prostate cancer

NCT ID NCT04986423

Disease control Sponsor: Zenith Epigenetics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2b trial tests whether adding an experimental drug called ZEN003694 to the standard drug enzalutamide can help men with metastatic castration-resistant prostate cancer that has stopped responding to abiraterone. About 200 men will be randomly assigned to receive either the combination or enzalutamide alone. The study separates patients based on how well they responded to prior abiraterone, and the main goal is to see if the combination delays cancer growth or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZEN003694 (ZEN-3694) combined with enzalutamide (Xtandi)
What this could lead to
If successful, this combination could offer a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is a mid-stage trial with only 200 participants, so results may not confirm benefit. The drug combination may cause side effects or fail to improve progression-free survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic castration resistant prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, 230002, China

  • BRCR Global

    RECRUITING

    Plantation, Florida, 33322, United States

  • California Research Institute

    RECRUITING

    Los Angeles, California, 90027, United States

  • Chongqing Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Colorado Urology

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • D&H Cancer Research Center, LLC

    RECRUITING

    Margate, Florida, 33063, United States

  • First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, 030001, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Hematology Oncology Clinic

    WITHDRAWN

    Baton Rouge, Louisiana, 70809, United States

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410006, China

  • Innovative Clinical Research Institute

    RECRUITING

    Whittier, California, 90603, United States

  • Liaoning Cancer Hospital

    WITHDRAWN

    Shenyang, Liaoning, 110042, China

  • Maryland Oncology Hematology, P.A.

    RECRUITING

    Columbia, Maryland, 21044, United States

  • Messino Cancer Center

    RECRUITING

    Asheville, North Carolina, 28806, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Northwest Cancer Specialists, P.C.

    RECRUITING

    Portland, Oregon, 97223, United States

  • Seattle Cancer Care Alliance

    RECRUITING

    Seattle, Washington, 98109, United States

  • Shanghai Tenth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200072, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610072, China

  • Texas Oncology - Central South

    RECRUITING

    Austin, Texas, 78731, United States

  • The First Affiliated Hospital of Xi'an Jiaotang University

    RECRUITING

    Xi'an, Shaanxi, 71000, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Urology Associates, P.C.

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Weill Cornell Medical College - New York Presbyterian Hospital

    COMPLETED

    New York, New York, 10065, United States

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310014, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.