Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer

NCT07236112 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TR1229
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; PSMA PET

Outcome Measures

Primary Outcomes (1)

• the safety and tolerability of TRDC002 in participants

  Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  3 days

Secondary Outcomes (16)

• Pharmacokinetics of TRDC002.

  Within 1 minute, 10 minutes, and 30 minutes, and at 60 minutes, 2 hours, 6 hours and 24 hours for blood PK, and 0-60 minutes, 1-2 hours, 2-6 hours, and 6-24 hours for urine PK.

• Pharmacokinetics of TRDC002.

  Within 1 minute, 10 minutes, and 30 minutes, and at 60 minutes, 2 hours, 6 hours and 24 hours for blood PK, and 0-60 minutes, 1-2 hours, 2-6 hours, and 6-24 hours for urine PK.

• Pharmacokinetics of TRDC002.

  Within 1 minute, 10 minutes, and 30 minutes, and at 60 minutes, 2 hours, 6 hours and 24 hours for blood PK, and 0-60 minutes, 1-2 hours, 2-6 hours, and 6-24 hours for urine PK.

• The biodistribution of TRDC002.

  At 1 hour, 4 hours, 7 hours, and 24 hours post injection.

• The biodistribution of TRDC002.

  At 1 hour, 4 hours, 7 hours, and 24 hours post injection.

Other Outcomes (2)

• The correct localization rate (CLR) of TRDC002 PET/CT imaging

  At 1 hour, 4 hours, 7 hours, and 24 hours post injection.

• The patient-level correct detection rate (CDR) of TRDC002 PET/CT imaging

  At 1 hour, 4 hours, 7 hours, and 24 hours post injection.

Study Arms (2)

4 mCi of TRDC002

EXPERIMENTAL

Patients receive 4±0.5mCi (148±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.

Drug: Intravenous (IV) single dose

6 mCi of TRDC002

EXPERIMENTAL

Patients receive 6±0.5mCi (222±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.

Drug: Intravenous (IV) single dose

Interventions

Intravenous (IV) single dose DRUG

Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.

4 mCi of TRDC002; 6 mCi of TRDC002

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any immunotherapy or biological therapy (including antibodies) targeting PSMA within 60 days prior to the day of randomization.
• A superscan is observed in the baseline bone scan.
• Concurrent serious (as determined by the Investigator) medical conditions
• Participants with symptomatic brain metastases, meningeal metastases, or spinal cord compression.

Sponsors & Collaborators

• C Ray Therapeutics: lead

Study Sites (2)

Union Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yan Wu, MD

  C Ray Therapeutics (Chengdu) Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Three independent readers will be blinded to all participants information and doses administered.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Enrolled participants will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: February 8, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)