Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis

Prostate Cancer Clinical Trial

Official title:

Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06462508
• Other study ID #: PSMA PET STUDY -02
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 20, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Anhui Provincial Hospital
• Contact: Qiang Xie, MD
• Phone: +8613721108043
• Email: xieqiang1980[@]ustc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [18F]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11.

Description:

[18F]F-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [68Ga]Ga-PSMA-11 PET/CT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Aged from 18 to 90 years old;

• Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);

• Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;

• simultaneous [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 examinations within two weeks;

• Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;

• Sign informed consent.

Exclusion Criteria:

• Patients who cannot cooperate with the examination;

• Concurrent malignant tumors;

• Previous alcohol allergy;

• Patients with liver and kidney dysfunction;

• Other circumstances deemed by the investigator to be inappropriate for trial participation.

Related Conditions & MeSH terms

• PET/CT
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Drug:
• [18F]F-PSMA-N5
Each subject receive a single intravenous injection of [18F]F-PSMA-N5, and undergo PET/CT imaging within the specificed time.
• [68Ga]Ga-PSMA-11
Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of China University of Science and Technology(Anhui Provincial Hospital)	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard uptake value(SUV)	Standard uptake value(SUV) of [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 for each target lesion of subjects.	30 days
Secondary	Diagnostic efficacy	The sensitivity, specificity and accuracy of [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 PET/CT were calculated.	30 days
Secondary	Number of lesions	The number of lesions detected by [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 PET/CT.	30 days