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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-PSMA-33
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate-Specific Membrane Antigen (PSMA), PET/CT, Prostate cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • 68Ga-PSMA-33 PET/CT imagingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-PSMA-33

Arm Description

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).

Outcomes

Primary Outcome Measures

Tumor detection rate
Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Standardized uptake value (SUV) of tumor
Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.

Secondary Outcome Measures

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).

Full Information

First Posted
September 12, 2023
Last Updated
September 19, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06054789
Brief Title
Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
Official Title
Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate-Specific Membrane Antigen (PSMA), PET/CT, Prostate cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-PSMA-33
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA-33
Other Intervention Name(s)
68Ga-PSMA-617
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tumor detection rate
Description
Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Time Frame
2 years
Title
Standardized uptake value (SUV) of tumor
Description
Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Description
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).
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Wang
Phone
02552271276
Email
fengwangcn@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenyu Wu
Phone
02552271276
Email
15150513147@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
68Ga-PSMA-33 PET/CT imaging
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyu Wu
Phone
02552271276
Email
15150513147@163.com

12. IPD Sharing Statement

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

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