Clinical trial Recruiting at 1 site Early Phase 1 Interventional Ages 18 to 90 Men only

Comparing two PET imaging agents for prostate cancer diagnosis

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

Run by Anhui Provincial Hospital · NCT06756334 · Data updated 2026-11-12

This study is testing a new PET imaging agent for prostate cancer to see if it works better than an existing one in diagnosing the disease and spotting any spread or recurrence.

Quick facts

PhaseEarly Phase 1
Study typeInterventional
Ages18 Years to 90 Years
SexMen only
Enrollment30 (estimated)
SponsorAnhui Provincial Hospital
Government
Locations1 site (Hefei, Anhui)
StatusRecruiting
StartedDecember 19, 2024
Main results expectedJune 30, 2025
Study endsDecember 31, 2025
Registry record updatedJanuary 3, 2025
Trial IDNCT06756334 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men aged 18 to 90 with prostate cancer or suspected recurrence who are willing to undergo imaging and potential biopsy.

Probably not a fit

Patients with concurrent malignancies, severe liver or kidney dysfunction, or those unable to cooperate with the examination may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a new PET imaging agent, [18F]AlF-PSMA-N5, in diagnosing prostate cancer, detecting recurrence, and identifying metastasis. It involves a head-to-head comparison with another agent, [18F]F-DCFPyL, to assess their biodistribution and diagnostic accuracy. Patients will undergo both imaging examinations within a two-week period, and various metrics such as sensitivity and specificity will be calculated to determine the superior agent.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic accuracy for prostate cancer, enhancing patient outcomes.

How similar studies have gone: While there have been studies on PET imaging agents for prostate cancer, this specific comparison of [18F]AlF-PSMA-N5 and [18F]F-DCFPyL is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 \[18F\]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.

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.

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.