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New hope for Hard-to-Treat prostate cancer? early trial launches

NCT ID NCT07332455

Disease control Sponsor: GlaxoSmithKline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 17, 2026 · Updated 5 times

Summary

This early-phase trial is testing a new drug called GSK5471713 in 54 men with metastatic castration-resistant prostate cancer that has worsened despite standard treatments. The study aims to find a safe dose and see if the drug can shrink tumors or lower PSA levels. It is the first time this drug is being tested in humans.

What this could mean

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

Active substance
GSK5471713
What this could lead to
If successful, this could point toward a new treatment option for advanced prostate cancer that has stopped responding to standard therapies.
What could go wrong
This is an early first-in-human trial with only 54 participants, so safety and effectiveness are not yet established. Many experimental drugs fail to show benefit in later stages.

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 54 people

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

Started

Feb 2026

Expected to finish

Mar 2030

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: * Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. * Progression on ADT and \>=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens. Exclusion Criteria: * Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma. * Impaired cardiac function or clinically significant cardiac disease. * Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality. * Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

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

Neoplasms, prostate

How to take part

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

  1. The places running it

    16 sites in 8 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

  • GSK Investigational Site

    RECRUITING

    La Jolla, California, 92093, United States

  • GSK Investigational Site

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • GSK Investigational Site

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • GSK Investigational Site

    RECRUITING

    West Valley City, Utah, 84119-3602, United States

  • GSK Investigational Site

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    RECRUITING

    Montpellier, 34298, France

  • GSK Investigational Site

    RECRUITING

    Tokyo, 104-0045, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 135-8550, Japan

  • GSK Investigational Site

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • GSK Investigational Site

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • GSK Investigational Site

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 120-752, South Korea

  • GSK Investigational Site

    RECRUITING

    Logroño, 26006, Spain

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