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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054789
• Other study ID #: 68Ga-PSMA-33
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Feng Wang
• Phone: 02552271276
• Email: fengwangcn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 68Ga-PSMA-33
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.

Locations

Country	Name	City	State
China	68Ga-PSMA-33 PET/CT imaging	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor detection rate	Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.	2 years
Primary	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	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