New radioactive therapy targets Hard-to-Treat prostate cancer
NCT ID NCT07567521
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital
RECRUITINGTaiyuan, Shanxi, 030013, China
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Fudan University Shanghai Cancer Center
NOT_YET_RECRUITINGShanghai, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?