Comparing two PET imaging agents for prostate cancer diagnosis
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
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
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06756334 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hefei, Anhui
- The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital） — Hefei, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Qiang Xie, MD
- Email: xieqiang1980@ustc.edu.cn
- Phone: 13721108043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.