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New radioactive therapy targets Hard-to-Treat prostate cancer

NCT ID NCT07567521

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called TRC003 for men with a type of advanced prostate cancer that has spread and is no longer responding to hormone therapy or chemotherapy. TRC003 is a radioactive molecule designed to attach to prostate cancer cells and deliver radiation directly to kill them. The trial will enroll 90 participants to evaluate safety, dosing, and early signs of effectiveness.

What this could mean

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

Active substance
TRC003 (a radioactive molecule that targets and kills prostate cancer cells)
What this could lead to
If successful, this could offer a new treatment option for men with advanced prostate cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with only 90 participants, so it is not yet proven to be safe or effective. Radioactive treatments can cause side effects like damage to healthy tissues.

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 90 people

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

Started

May 2026

Expected to finish

Dec 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.

Inclusion Criteria: * Participants must have the ability to understand and sign ICF. * Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. * Participants must have progressive mCRPC after treatment of ARPI or taxane-based chemotherapy. * Participant must have been diagnosed with mCRPC with documented progressive disease. * Participants must have prior orchiectomy and/or ongoing androgen-deprivation therapy with a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Participants must have one or more PSMA-positive lesions whose PSMA uptake (SUVmax) is more than 2 fold of the blood pool. * Participants with an ECOG performance status of 0 - 2. * Participants must have adequate organ function * For participants who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal Investigator during the study and for 6 months after last investigational product administration. Exclusion Criteria: * Participants with mixed histology of prostate cancer (e.g., neuroendocrine). * Any FDG-positive and PSMA-negative target lesions. * Any investigational agents and other concurrent chemotherapy, targeted therapy, biologic agents, immunotherapy, radioligand therapy (androgen-deprivation therapy excepted) within 28 days or 5 half-lives prior to day of administration, whichever is longer. * Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks before enrollment. * Previous bone-targeted therapy cannot be taken with a stable dose within 4 weeks before enrollment. * Known hypersensitivity to the components of the study therapy or its analogs. * Transfusion for the sole purpose of making a participant eligible for study inclusion within 28 days before administration. * A superscan as seen in the baseline bone scan. * Concurrent serious (as determined by the Investigator) medical conditions. * Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.

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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

    2 sites. 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

  • Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital

    RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, 200032, China

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