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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
6
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
Union Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Shandong Cancer Hospital
Jinan, Shandong, China
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.
Time frame: 3 days
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.
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.
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.
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.
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.
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.
Biodistribution will be performed by average Standardized Uptake Value Maximum (SUVmax) of TRDC002 uptake in healthy organs and tumors.
Time frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
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The biodistribution of TRDC002.
Biodistribution will be performed by average Standardized Uptake Value Mean (SUVmean) of TRDC002 uptake in healthy organs and tumors.
Time frame: 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.
Time frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Dosimetry will be assessed by absorbed dose.
Time frame: 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).
Time frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Dosimetry will be assessed by effective dose.
Time frame: 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.
Time frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.
The dosimetry of TRDC002.
Dosimetry will be assessed by residence time.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: At 1 hour, 4 hours, 7 hours, and 24 hours post injection.