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

Last updated: December 25, 2024
Sponsor: Anhui Provincial Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Prostate Disorders

Treatment

[18F]AlF-PSMA-N5

[18F]F-DCFPyL

Clinical Study ID

NCT06756334
PSMA PET STUDY -03
  • Ages 18-90
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 suspectedrecurrence 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 afterexamination, or confirmed as prostate cancer by histopathology before or aftertreatment;

  • Sign informed consent.

Exclusion

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 trialparticipation.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: [18F]AlF-PSMA-N5
Phase: 1
Study Start date:
December 19, 2024
Estimated Completion Date:
December 31, 2025

Study Description

[18F]AlF-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 [18F]F-DCFPyL PET/CT.

Connect with a study center

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

    Hefei, Anhui 230000
    China

    Active - Recruiting

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