Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-PSMA-33 in patient with Prostate Cancer (PCa).

Detailed Description
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This study is design to prospectively investigate the safety and efficacy of 68Ga-PSMA-33 in the early diagnosis of Prostate Cancer (PCa). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-PSMA-33 in patient with PCa. While PSMA is expressed at low levels in normal prostate epithelium, it is overexpressed (up to 1000 times higher) in 90-95% of prostate cancers, make PSMA an attractive target for the diagnosis and treatment of PCa. 68Ga-PSMA-33 as a new PSMA targeted probe was prepared and showed good uptake on PCa cell line and animal studies. The study intends to recruit 8 PCa volunteers to participate in the experiment. All patients were intravenously injected with 68Ga-PSMA-33 and underwent PET/CT at 0.5, 1, 2 and 4 h, respectively. For comparison, 3 patients were additionally received 68Ga-PSMA-617 PET/CT imaging. The images were interpreted by two experienced physician and the SUVmax or SUVmean of physiological organs and tumor lesions were collected.

Official Title
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Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 68Ga-PSMA-33


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male sex Age 18 years or older Patients must have histologically or cytologically confirmed localized or metastatic prostate cancer Creatinine less than or equal to 1.5 X upper limit of normal ECOG performance status 0 - 2, inclusive Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation Patient with complete clinical data. The effects of 68Ga-PSMA-33 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Able to understand and provide written informed consent Exclusion Criteria: Patient age < 18 years Received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives Malignancy other than current disease under study Patient simultaneously participating in another clinical trial Patient who cannot stay on PET/CT Patient with HIV, HCV, HVB infection or other serious chronic infection Patient with liver and kidney function (GFR less than 50 ml/min) disease Cannot receive furosemide, allergy to sulfa or sulfa-containing medications Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-PSMA-33<br>For the injection, subjects will receive a target dose of 3-7mCi 68Ga-PSMA-33 as a bolus injection. Among them, 3 4 subjects will additionally inject with 68Ga-PSMA-617 (3-7mCi). | Drug: 68Ga-PSMA-33<br>* Subjects will receive one injection of 68Ga-PSMA-33/PSMA-617 (3-7mCi ), a PET radiopharmaceutical selective for Prostate-Specific Membrane Antigen. 68Ga-PSMA-33/PSMA-617 injection will be followed by a 10 ml saline flush.<br>* Other names: 68Ga-PSMA-617;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor detection rate | Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT. | 2 years | 
| Standardized uptake value (SUV) of tumor | Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Profile Measured by Adverse Events (AEs) | Safety and tolerability profile for the administration of 68Ga-PSMA-33 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate-Specific Membrane Antigen (PSMA), PET/CT, Prostate cancer