Prostate CancerPhase 1/2NCT07567521
A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPC
A Phase 1/2 study testing Radiopharmaceuticals in people with Prostate Cancer, run by C Ray Therapeutics at 2 sites in China.
Trial summary
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. 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?
- Radiopharmaceuticals
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 22 May 2026to 30 Dec 2029
- Phase
- Phase 1/2
- 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 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.
Show all 9Show fewer
- 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.
Who cannot join
- Participants with mixed histology of prostate cancer (e.g., neuroendocrine).
- Any FDG-positive and PSMA-negative target lesions.
- 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.
- Known hypersensitivity to the components of the study therapy or its analogs.
Show all 10Show fewer
- Transfusion for the sole purpose of making a participant eligible for study inclusion within 28 days before administration.
- A superscan as seen in the baseline bone scan.
- Concurrent serious (as determined by the Investigator) medical conditions.
- Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Ying Shen, MD, PhD, 086-021-64175590, yshen@shca.org.cn
Dingwei Ye, MD, PhD
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences, Shanxi Hospital
Taiyuan, Shanxi, 030013
Sujun Han, MD, PhD, 086-0351-4881611, hsjyz2022@163.com
Nianzeng Xing, MD, PhD
About this study
Official title: 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.
Read the detailed description
This is a prospective, randomized, open-label, phase 1/2 study on adult patients with PSMA-positive metastatic castration-resistant prostate cancer. Approximately 90 eligible participants will be enrolled and randomized 1:1:1 to three dose cohorts. The first six participants in each cohort will be assessed for dose-limiting toxicity (DLT) during the first treatment cycle.
Each eligible participant will receive one of the predefined doses of TRC003 (7.40, 9.25, 11.10 MBq) by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. All participants in this study may undergo dose modification based on the assessment of safety or efficacy by the investigators.
Any adverse events (AEs) observed or reported will be recorded. Blood and urine samples will be collected after the first administration of TRC003 on 6 participants in each cohort for pharmacokinetics (blood concentration of TRC003). 2 eligible participants of each cohort (total 6 participants) will undergo SPECT/CT for dosimetry after informed consent. All participants will be assessed PSA every 4 weeks. CT with contrast /MRI and bone scan will be evaluated every 8 weeks until proved disease progression by RECIST version 1.1 and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
- Conditions
- Prostate Cancer
- Being tested
- Radiopharmaceuticals
- Keywords
- Radiopharmaceutical Therapy, prostate cancer, Prostate Specific Membrane Antigen
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiopharmaceuticalsDrug
TRC003 is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. TRC003 is a 225Ac-labeled novel molecule for targeted alpha therapy (TAT), which delivers alpha-particle radiation specifically to prostate cancer cells expressing PSMA. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them.
| Study group | Role | What they receive |
|---|---|---|
| 7.40MBq of TRC003 | Experimental | Participants will receive 7.40 MBq (200 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. Receives: Drug: Radiopharmaceuticals |
| 9.25 MBq of TRC003 | Experimental | Participants will receive 9.25 MBq (250 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. Receives: Drug: Radiopharmaceuticals |
| 11.10 MBq of TRC003 | Experimental | Participants will receive 11.10 MBq (300 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. Receives: Drug: Radiopharmaceuticals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs and SAEs
Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) by monitoring adverse events, laboratory tests, vital signs, Electrocardiogram(ECG).
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Prostate Specific Antigen response (PSA50)
The percentage of participants who achieved ≥ 50% decrease from baseline at 12 weeks after the first administration or later.
Measured: About 12 months.
Secondary outcomes (17)
Peak concentration (Cmax)
The maximum measured concentration of TRC003 in the body after administration.
Measured: 10 days following the first dose.
AUC0-t
Area under the concentration-time curve from time 0 to the last measurable concentration
Measured: 10 days following the first dose.
T1/2
Time required for the drug concentration to decrease by 50%.
Measured: 10 days following the first dose.
Absorbed dose coefficients
The ratio of absorbed dose in a target tissue to the total activity injected, representing dose delivered per unit activity.
Measured: 10 days following the first dose.
Residence time
The total time that TRC003 remains in a target organ or the body.
Measured: 10 days following the first dose.
Effective dose
Effective dose is the total radiation dose adjusted for organ sensitivity, used to estimate the risk of radiation-induced health effects.
Measured: 10 days following the first dose.
Prostate Specific Antigen response (PSA90)
The percentage of participants who achieved ≥ 90% decrease from baseline at 12 weeks after the first administration or later
Measured: About 12 months.
Biochemical Progression Free Survival (bPFS)
Time to PSA progression by PCWG3 criteria (after decline from baseline: record time from start of therapy to first PSA increase that is ≥ 25% and ≥ 2 ng/mL above the nadir, and which is confirmed by a second value ≥ 3 weeks later).
Measured: About 12 months.
Overall Response Rate (ORR)
The proportion of participants with Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) from baseline until radiographic progression or death, whichever comes first.
Measured: About 12 months
Disease Control Rate (DCR)
The proportion of participants with BOR of confirmed CR, PR, Stable Disease (SD) or non-CR/non-progressive disease (PD) from baseline until radiographic progression or death, whichever comes first.
Measured: About 12 months.
Duration of Response (DoR)
Time between the date of first documented response and the date of first documented radiographic progression or death due to any cause by RECIST v1.1 and PCWG3 criteria.
Measured: About 12 months.
Time to first radiographic Soft Tissue Progression (TTSTP)
Time to radiographic soft tissue progression by RECIST v1.1 and PCWG3 criteria.
Measured: About 12 months.
Time to Progression (TTP)
Time to the first documented radiographic progression by RECIST v1.1 and PCWG3 criteria.
Measured: About 12 months.
Time to first Symptomatic Skeletal Event (TTSSE)
Time to the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first.
Measured: About 12 months.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
A qusetionnaire to assess health-related quality of life (HRQOL) in cancer patients by patient-reported outcome (PRO) measure. The standard range of EORTC QLQ-C30 is 0-100 points. For Functional Scales, higher score means better function, better health status, higher quality of life. For Symptom Scales \& Single Symptom Items, higher score means more severe symptoms / greater burden.
Measured: About 12 months.
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
A disease-specific, patient-reported outcome (PRO) questionnaire designed to measure health-related quality of life (HRQoL) in men with prostate cancer. FACT-P Total Score range is 0-160. Higher score means better quality of life, fewer symptoms, better functional status.
Measured: About 12 months.
Brief Pain Inventory - Short Form (BPI-SF)
A widely used, validated patient-reported outcome (PRO) tool designed to assess the severity of pain and the impact of pain on daily functioning. BPI-SF Total Score range is 0-110. Higher total score means worse overall pain and greater pain interference with daily life.
Measured: About 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start22 May 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2029 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C Ray Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Wu, MD, Study director, C Ray Therapeutics (Chengdu) Co., Ltd.Dingwei Ye, MD, PhD, Study chair, Fudan University Shanghai Cancer Center, Fudan UniversityNianzeng Xing, MD, PhD, Study chair, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567521
- Sponsor's protocol ID
- TR1189-2501-1
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07567521
- Acronym / sponsor ID
- TR1189-2501-1
- Conditions
- Prostate Cancer
- Keywords
- Radiopharmaceutical Therapy, prostate cancer, Prostate Specific Membrane Antigen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- C Ray TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 May 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 5 May 2026 (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.
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.
Detailed description
This is a prospective, randomized, open-label, phase 1/2 study on adult patients with PSMA-positive metastatic castration-resistant prostate cancer. Approximately 90 eligible participants will be enrolled and randomized 1:1:1 to three dose cohorts. The first six participants in each cohort will be assessed for dose-limiting toxicity (DLT) during the first treatment cycle.
Each eligible participant will receive one of the predefined doses of TRC003 (7.40, 9.25, 11.10 MBq) by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. All participants in this study may undergo dose modification based on the assessment of safety or efficacy by the investigators.
Any adverse events (AEs) observed or reported will be recorded. Blood and urine samples will be collected after the first administration of TRC003 on 6 participants in each cohort for pharmacokinetics (blood concentration of TRC003). 2 eligible participants of each cohort (total 6 participants) will undergo SPECT/CT for dosimetry after informed consent. All participants will be assessed PSA every 4 weeks. CT with contrast /MRI and bone scan will be evaluated every 8 weeks until proved disease progression by RECIST version 1.1 and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7.40MBq of TRC003 | Experimental | Drug: RadiopharmaceuticalsParticipants will receive 7.40 MBq (200 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. |
| 9.25 MBq of TRC003 | Experimental | Drug: RadiopharmaceuticalsParticipants will receive 9.25 MBq (250 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. |
| 11.10 MBq of TRC003 | Experimental | Drug: RadiopharmaceuticalsParticipants will receive 11.10 MBq (300 μCi) ±10% of TRC003 by intravenous infusion every 8 weeks (±1 week) for a maximum of 6 cycles if participants benefit from the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- Participants with mixed histology of prostate cancer (e.g., neuroendocrine).
- Any FDG-positive and PSMA-negative target lesions.
- 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.
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 |
|---|---|---|
| RadiopharmaceuticalsTRC003 is a radioligand therapeutic agent indicated for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. TRC003 is a 225Ac-labeled novel molecule for targeted alpha therapy (TAT), which delivers alpha-particle radiation specifically to prostate cancer cells expressing PSMA. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. | Drug | 11.10 MBq of TRC003, 7.40MBq of TRC003, 9.25 MBq of TRC003 |
Primary outcome
Incidence and severity of AEs and SAEs
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) by monitoring adverse events, laboratory tests, vital signs, Electrocardiogram(ECG).
Prostate Specific Antigen response (PSA50)
Time frame: About 12 months.
The percentage of participants who achieved ≥ 50% decrease from baseline at 12 weeks after the first administration or later.
17 secondary outcomes
Peak concentration (Cmax)
Time frame: 10 days following the first dose.
AUC0-t
Time frame: 10 days following the first dose.
T1/2
Time frame: 10 days following the first dose.
Absorbed dose coefficients
Time frame: 10 days following the first dose.
Residence time
Time frame: 10 days following the first dose.
Effective dose
Time frame: 10 days following the first dose.
Prostate Specific Antigen response (PSA90)
Time frame: About 12 months.
Biochemical Progression Free Survival (bPFS)
Time frame: About 12 months.
Overall Response Rate (ORR)
Time frame: About 12 months
Disease Control Rate (DCR)
Time frame: About 12 months.
Duration of Response (DoR)
Time frame: About 12 months.
Time to first radiographic Soft Tissue Progression (TTSTP)
Time frame: About 12 months.
Time to Progression (TTP)
Time frame: About 12 months.
Time to first Symptomatic Skeletal Event (TTSSE)
Time frame: About 12 months.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: About 12 months.
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Time frame: About 12 months.
Brief Pain Inventory - Short Form (BPI-SF)
Time frame: About 12 months.
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 29 May 2026.
- Individual participant dataSharing planned: Yes
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.
Yan Wu, MD study director
C Ray Therapeutics (Chengdu) Co., Ltd.
Dingwei Ye, MD, PhD study chair
Fudan University Shanghai Cancer Center, Fudan University
Nianzeng Xing, MD, PhD study chair
Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiopharmaceuticals 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 May 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jihong Liu, PhD (86-28-82706670, jihong.liu@c-raytherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs and SAEs (time frame: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.). The study lists 2 primary outcomes in all. 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 29 May 2026.