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

NCT ID NCT06785636

Disease control Sponsor: Pathos AI, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 2 times

Summary

This study tests a new oral drug called pocenbrodib, alone or with another drug (darolutamide), in 120 men with metastatic castration-resistant prostate cancer (mCRPC). The goal is to find safe doses and see if the combination can slow cancer growth. It is an early-stage trial, so results will guide future research rather than offer immediate treatment.

What this could mean

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

Active substance
Pocenbrodib (a targeted oral drug) alone or with darolutamide
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 trial (Phase 1b/2a) focused on safety and dosing, so it is too soon to know if the drug will be effective. Side effects are unknown, and the combination may not work better than existing treatments.

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 120 people

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

Started

Feb 2025

Expected to finish

Apr 2029

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.

1b / 2a Inclusion Criteria: 1. ≥18 years of age 2. Histologic documentation of prostate adenocarcinoma 3. Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable 1b / 2a Exclusion Criteria: 1. Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy. 2. Any liver metastases confirmed by biopsy or evidence of lesions \>1 cm consistent with liver metastases on imaging. 3. Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Cycle 1 Day 1 or 5 half-lives (whichever is shorter). 4. Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complications. 2a only -key inclusion criteria: 1. Must have received at least 2 cycles of PLUVICTO® 2. 1 line of prior any ARPI therapy 3. No prior chemotherapy for mCRPC

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma male reproductive organ cancer metastatic prostate carcinoma neoplasm prostate cancer prostate disorder prostate neoplasm

As listed by the trial registrant

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

Genital neoplasms, male Male urogenital diseases MCRPC (metastatic castration-resistant prostate cancer) Neoplasms Neoplasms by site Prostate cancer Prostatic diseases Prostatic neoplasms Urogenital cancers Urogenital neoplasms

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Cancer and Blood Research Center

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Community Health Network

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Duke University medical center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Memorial Sloan-Kettering Cancer Center (Mskcc)

    RECRUITING

    New York, New York, 10065, United States

  • MemorialCare Orange Coast Medical Center

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Mount Sinai Medical Center

    RECRUITING

    Miami, Florida, 33140, United States

  • NEXT Oncology - Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Ochsner

    RECRUITING

    Jefferson, Louisiana, 70121, United States

  • Oncology Consultants, P.A

    RECRUITING

    Houston, Texas, 77030, United States

  • Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63108, United States

  • Taylor Cancer Research Center

    RECRUITING

    Maumee, Ohio, 43537, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Colorado Health

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

More trials for these conditions

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