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

NCT06756334 | Recruiting Early Phase 1

• 1 other identifier: PSMA PET STUDY -03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]AlF-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 \[18F\]F-DCFPyL.

Conditions

Prostate Cancer; PET/CT

Outcome Measures

Primary Outcomes (1)

• Standard uptake value(SUV)

  Standard uptake value(SUV) of \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL for each target lesion of subjects.

  30 days

Secondary Outcomes (2)

• Diagnostic efficacy

  30 days

• Number of lesions

  30 days

Study Arms (1)

[18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan

EXPERIMENTAL

Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL.

Drug: [18F]AlF-PSMA-N5; Drug: [18F]F-DCFPyL

Interventions

[18F]AlF-PSMA-N5 DRUG

Each subject receive a single intravenous injection of \[18F\]AlF-PSMA-N5, and undergo PET/CT imaging within the specificed time.

[18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan

[18F]F-DCFPyL DRUG

Each subject receive a single intravenous injection of \[18F\]F-DCFPyL, and undergo PET/CT imaging within the specificed time.

[18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Qiang Xie, MD

  The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）

  STUDY CHAIR

Central Study Contacts

Qiang Xie, MD

CONTACT

13721108043; xieqiang1980@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 3, 2025
• Study Start: December 19, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)