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

April 14, 2026 updated by: C Ray Therapeutics

A Prospective, Randomized, Open-label, Phase I Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Recurrent or Metastatic Prostate Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, open-label, phase I study to evaluate safety and tolerability, PK, biodistribution, dosimetry and preliminary efficacy of TRDC002 for PET/CT imaging in participants with PSMA-positive recurrent or metastatic prostate cancer compared with CRS.

At screening, the participants will be assessed for eligibility and will undergo PSMA PET to screen PSMA positive patients.

Eligible participants with recurrent or metastatic prostate cancer will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002 intravenously. Whole-body PET/CT images will be acquired at 1hr, 4hr, 7hr, and 24hr post-injection to observe radiation absorbed dose and pharmacokinetics. Independent review committee (IRC) will evaluate the quality of PET images to determine an acceptable dose and optimal acquisition time for PET scan, and preliminary efficacy compared with Composite Reference Standard (CRS) based on CT/MRI with contrast and bone scan.

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College of Huazhong University of Science and Technology
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4 mCi of TRDC002
Patients receive 4±0.5mCi (148±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.
Drug: Intravenous (IV) single dose
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
Experimental: 6 mCi of TRDC002
Patients receive 6±0.5mCi (222±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.
Drug: Intravenous (IV) single dose
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the safety and tolerability of TRDC002 in participants
Time Frame: 3 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of TRDC002.
Time Frame: 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.
Peak plasma concentration (Cmax) will be performed by a bioanalytical HPLC method, free 64Cu, and known radiolysis byproducts of TRDC002 in plasma and urine samples.
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.
Time Frame: 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.
Area under the plasma concentration versus time curve (AUC) will be performed by a bioanalytical HPLC method, free 64Cu, and known radiolysis byproducts of TRDC002 in plasma and urine samples.
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.
Time Frame: 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.
Apparent elimination half-life (T1/2) will be performed by a bioanalytical HPLC method, free 64Cu, and known radiolysis byproducts of TRDC002 in plasma and urine samples.
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.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Biodistribution will be performed by average Standardized Uptake Value Maximum (SUVmax) of TRDC002 uptake in healthy organs and tumors.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The biodistribution of TRDC002.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Biodistribution will be performed by average Standardized Uptake Value Mean (SUVmean) of TRDC002 uptake in healthy organs and tumors.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The biodistribution of TRDC002.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Biodistribution will be performed by average injective dose (%ID) of TRDC002 uptake in healthy organs and tumors.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Dosimetry will be assessed by absorbed dose.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Dosimetry will be assessed by absorbed dose coefficients (ADC).
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Dosimetry will be assessed by effective dose.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Dosimetry will be assessed by effective dose per administered activity.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Dosimetry will be assessed by residence time.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
PET/CT images to determine an acceptable dose and optimal acquisition time of PET scan.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Image quality score will be used to judge the optimal dose level yielding diagnostic images at optimal acquisition time post-injection by majority of three readers.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
PET/CT images to determine an acceptable dose and optimal acquisition time of PET scan.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Signal-to-noise ratio (SNR) will be used to judge the optimal dose level yielding diagnostic images at optimal acquisition time post-injection by majority of three readers.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
PET/CT images to determine an acceptable dose and optimal acquisition time of PET scan.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Tumor-to-background ratio (TBR) will be used to judge the optimal dose level yielding diagnostic images at optimal acquisition time post-injection by majority of three readers.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
PET/CT images to determine an acceptable dose and optimal acquisition time of PET scan.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Lesion-to-blood pool ratio (LBR) will be used to judge the optimal dose level yielding diagnostic images at optimal acquisition time post-injection by majority of three readers.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
PET/CT images to determine an acceptable dose and optimal acquisition time of PET scan.
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Lesion-to -muscle ratio (LMR) will be used to judge the optimal dose level yielding diagnostic images at optimal acquisition time post-injection by majority of three readers.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correct localization rate (CLR) of TRDC002 PET/CT imaging
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The region-level correct localization rate (CLR) of TRDC002 PET/CT imaging at different timepoints after administration.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The patient-level correct detection rate (CDR) of TRDC002 PET/CT imaging
Time Frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The patient-level correct detection rate (CDR) of TRDC002 PET/CT imaging for the detection of recurrent or metastatic prostate cancer at different timepoints after administration.
At 1 hour, 4 hours, 7 hours, and 24 hours post injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C Ray Therapeutics

Investigators

  • Study Chair: Yan Wu, MD, C Ray Therapeutics (Chengdu) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2026

Primary Completion (Actual)

April 1, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 15, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR1229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We regret to inform you that we do not plan to share the Individual Participant Data (IPD) of this study due to the limited sample size. Thanks for your kind understanding.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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