Testing TRC003, a radiopharmaceutical, in advanced prostate cancer that has kept growing
Tests TRC003 in adults with advanced prostate cancer that has kept growing.
Plain-language title generated from the registry record
Registry title: A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC
Key facts
- Where
- Shanghai and Taiyuan, ChinaSee the 2 sites
- Phase
- Phase 1/2
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaNot yet recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi HospitalTaiyuan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- C Ray Therapeutics
- Trial code
- NCT07567521
- Record updated
- 29 May 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Open-label, Randomized, Phase 1/2 Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)
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.
Inclusion: 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: 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; Transfusion for the sole purpose of making a participant eligible for study inclusion within 28 days before administration; Concurrent serious (as determined by the Investigator) medical conditions; Participants with mixed histology of prostate cancer (e.g., neuroendocrine); Known hypersensitivity to the components of the study therapy or its analogs; Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment; Any FDG-positive and PSMA-negative target lesions; A superscan as seen in the baseline bone scan.