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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mCi of TRDC002 | Experimental | Patients receive 4±0.5mCi (148±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan. |
|
| 6 mCi of TRDC002 | Experimental | Patients receive 6±0.5mCi (222±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous (IV) single dose | Drug | Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The correct localization rate (CLR) of TRDC002 PET/CT imaging | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Wu, MD | C Ray Therapeutics (Chengdu) Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China | ||
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.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Enrolled participants will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002.
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Three independent readers will be blinded to all participants information and doses administered.
| 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. | 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. | 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. | 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. | 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. | At 1 hour, 4 hours, 7 hours, and 24 hours post injection. |
| The dosimetry of TRDC002. | Dosimetry will be assessed by absorbed dose. | 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). | At 1 hour, 4 hours, 7 hours, and 24 hours post injection. |
| The dosimetry of TRDC002. | Dosimetry will be assessed by effective dose. | 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. | At 1 hour, 4 hours, 7 hours, and 24 hours post injection. |
| The dosimetry of TRDC002. | 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. | 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. | 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. | 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. | 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. | 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. |
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. |
| Shandong Cancer Hospital |
| Jinan |
| Shandong |
| 250117 |
| China |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |