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Promising prostate cancer drug gets extended trial for those already benefiting

NCT ID NCT04145375

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 trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial gives men with metastatic castration-resistant prostate cancer (mCRPC) continued access to the experimental drug ZEN003694, often combined with enzalutamide (Xtandi), if they are already seeing benefits from it in a previous study. About 40 participants will be enrolled to monitor side effects and long-term outcomes like tumor response and survival. The goal is to keep providing a potentially helpful treatment while gathering more safety data.

What this could mean

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

Active substance
ZEN003694 (a drug) and enzalutamide (Xtandi)
What this could lead to
If successful, this could offer a way for men with advanced prostate cancer to keep receiving a promising treatment that is helping them.
What could go wrong
This is an early-phase continuation study with only 40 participants, so results may not apply broadly. Side effects are possible, and the drug is still investigational.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

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

Started

Nov 2019

Expected to finish

Dec 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

Anyone

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. Protocol-defined completion in a parent ZEN003694 trial 2. Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol 3. ECOG performance status of 0 or 1 4. Acceptable ZEN003694 tolerability, in the judgment of the investigator 5. Initiation of dosing in this continuation trial to occur within two weeks (14 days) of completing dosing in the parent trial, unless more time is approved by the sponsor in writing Exclusion Criteria: 1. Concurrent participation in another clinical investigational treatment trial 2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study 3. Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study 4. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

MCRPC

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • University of California San Francisco Medical Center

    San Francisco, California, 94104, United States

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