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New treatment option for Prostate Cancer
Official title A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC
ClinicalTrials.gov ID: NCT07567521
What this study is testing
What is Radiopharmaceuticals?
Radiopharmaceuticals is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate safety and tolerability, pharmacokinetics （PK）, efficacy of TRC003 injection in patients with progressive PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibitor (ARPI) or taxane-based chemotherapy. We plan to recruit 90 participants who will be randomly assigned to 1 of 3 dose cohorts (30 cases per dose cohort) with up to 6 cycles of treatment in this study.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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 \<...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taiyuan, Shanxi, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiyuan, Shanxi, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.