NCT07236112Active, not recruitingPhase 1
Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
A Prospective, Randomized, Open-label, Phase I Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Recurrent or Metastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
TRDC002 uses a radioactive form (64Cu) to trace the PSMA positive prostate cancer. The purpose of this study is to investigate TRDC002 as a PSMA PET tracer to localize PSMA positive lesions in adult patients with recurrent or metastatic prostate cancer. We plan to assess the PSMA PET/CT image quality following administration of two dose levels of TRDC002 to determine an acceptable dose and optimal acquisition time for obtaining diagnostic quality PET/CT images. The safety and tolerability, PK, biodistribution, dosimetry of TRDC002 will also be evaluated in this study.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- 8 Feb 2026
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- C Ray Therapeutics
- Diseases
- Prostate cancer
- NCT number
- NCT07236112
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 6
- From 8 Feb 2026 to the primary completion date, 1 Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any immunotherapy or biological therapy (including antibodies) targeting PSMA within 60 days prior to the day of randomization.
- Concurrent serious (as determined by the Investigator) medical conditions
Other
- A superscan is observed in the baseline bone scan.
- Participants with symptomatic brain metastases, meningeal metastases, or spinal cord compression.
Who the study is looking for
- Participants with recurrence or metastasis of prostate cancer.
- Participants with PSMA-positive lesions.
- Participants must have adequate bone marrow and organ function.
- Participants with an ECOG performance status of 0 or 1.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.