New hope for men with Hard-to-Treat prostate cancer?

NCT ID NCT06067841

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new drug called BMS-986460 in 140 men with metastatic castration-resistant prostate cancer, a type that no longer responds to standard hormone therapy. The main goals are to check the drug's safety and find the right dose, while also looking for signs that it might shrink tumors or lower PSA levels. Participants must have already tried at least one other hormone treatment.

What this could mean

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

Active substance
BMS-986460
What this could lead to
If successful, this could lead to a new treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is an early Phase 1 trial with only 140 participants, focused on safety. The drug may not prove effective or could have significant side effects.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 140 people

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

Started

Oct 2023

Expected to finish

Jul 2031

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: * Participant must have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Participant must have prostate specific antigen (PSA) of ≥ 2 ng/mL at Screening * Participant must have progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC) Exclusion Criteria: * Participant must not have history of brain metastases. * Participant must not have impaired cardiac function or clinically significant cardiac disease. * Participant must not have any significant medical condition, including active or uncontrolled infection, psychiatric illness, or the presence of laboratory abnormalities, which places the participant at unacceptable risk or prevent participation in the study based on Investigator assessment. Other protocol-defined inclusion/exclusion criteria apply

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.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    14 sites in 3 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

  • Centre Leon Berard

    RECRUITING

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Florida Cancer Specialists Sarasota Drug Development Unit

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, Val-de-Marne, 94800, France

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, Nan, 13009, France

  • Local Institution - 0006

    WITHDRAWN

    San Antonio, Texas, 78229, United States

  • Local Institution - 0009

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0011

    NOT_YET_RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Local Institution - 0017

    NOT_YET_RECRUITING

    Paris, 75015, France

  • Local Institution - 0018

    NOT_YET_RECRUITING

    Bordeaux, Aquitaine, 33076, France

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Stanford Cancer Center

    RECRUITING

    Palo Alto, California, 94304, United States

More trials for these conditions

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