Prostate CancerPhase 1NCT07236112
Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
A Phase 1 study testing Intravenous (IV) single dose in people with Prostate Cancer, run by C Ray Therapeutics at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Intravenous (IV) single dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesChina
- Study dates
- 8 Feb 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shandong Cancer Hospital
Jinan, Shandong, 250117
Union Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Intravenous (IV) single dose
- Keywords
- prostate cancer, PSMA PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous (IV) single doseDrug
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
| Study group | Role | What they receive |
|---|---|---|
| 4 mCi of TRDC002 | Experimental | Patients receive 4±0.5mCi (148±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan. Receives: 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. Receives: Drug: Intravenous (IV) single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (16)
Pharmacokinetics of TRDC002.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Biodistribution will be performed by average Standardized Uptake Value Maximum (SUVmax) of TRDC002 uptake in healthy organs and tumors.
Measured: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The biodistribution of TRDC002.
Biodistribution will be performed by average Standardized Uptake Value Mean (SUVmean) of TRDC002 uptake in healthy organs and tumors.
Measured: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The biodistribution of TRDC002.
Biodistribution will be performed by average injective dose (%ID) of TRDC002 uptake in healthy organs and tumors.
Measured: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Dosimetry will be assessed by absorbed dose.
Measured: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Dosimetry will be assessed by absorbed dose coefficients (ADC).
Measured: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Dosimetry will be assessed by effective dose.
Measured: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Dosimetry will be assessed by effective dose per administered activity.
Measured: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Dosimetry will be assessed by residence time.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start8 Feb 2026
- Primary completion1 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled participants will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C Ray Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Wu, MD, Study chair, C Ray Therapeutics (Chengdu) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236112
- Sponsor's protocol ID
- TR1229
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Phase I Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Recurrent or Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT07236112
- Acronym / sponsor ID
- TR1229
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, PSMA PET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- C Ray TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled participants will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002.
| Arm | Type | Receives |
|---|---|---|
| 4 mCi of TRDC002 | Experimental | Drug: Intravenous (IV) single dosePatients receive 4±0.5mCi (148±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan. |
| 6 mCi of TRDC002 | Experimental | Drug: Intravenous (IV) single dosePatients receive 6±0.5mCi (222±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous (IV) single doseDrug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging. | Drug | 4 mCi of TRDC002, 6 mCi of TRDC002 |
Primary outcome
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.
16 secondary outcomes
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.
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.
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.
The biodistribution of TRDC002.
Time frame: 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.
The biodistribution of TRDC002.
Time frame: 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.
The dosimetry of TRDC002.
Time frame: 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.
The dosimetry of TRDC002.
Time frame: 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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wu, MD study chair
C Ray Therapeutics (Chengdu) Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous (IV) single dose in people with Prostate Cancer, run by C Ray Therapeutics at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the safety and tolerability of TRDC002 in participants (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.