Prostate Cancer
Conditions
Keywords
prostate cancer, PSMA PET
Brief 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. 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.
Interventions
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
Sponsors
C Ray Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Three independent readers will be blinded to all participants information and doses administered.
Intervention model description
Enrolled participants will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the safety and tolerability of TRDC002 in participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of TRDC002. | 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. |
| The biodistribution of TRDC002. | 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. |
| The dosimetry of TRDC002. | At 1 hour, 4 hours, 7 hours, and 24 hours post injection. | Dosimetry will be assessed by absorbed dose. |
| PET/CT images to determine an acceptable dose and optimal acquisition time of PET scan. | 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. |
Countries
China
Contacts
STUDY_CHAIRYan Wu, MD
C Ray Therapeutics (Chengdu) Co., Ltd.
Outcome results
None listed