Comparing two PET imaging agents for prostate cancer diagnosis
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
This study is testing a new PET imaging agent for prostate cancer to see if it works better than an existing one in finding cancer and its spread in patients.
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 | NCT06462508 on ClinicalTrials.gov |
What this trial studies
This study evaluates the biodistribution and diagnostic efficacy of a new PET imaging agent, [18F]F-PSMA-N5, in prostate cancer patients. It aims to compare its performance with the established agent [68Ga]Ga-PSMA-11 in detecting prostate cancer, recurrence, and metastasis. The study will assess tumor uptake using maximum standardized uptake value (SUVmax) and calculate sensitivity, specificity, and accuracy of lesion identification across different organs. Participants will undergo both imaging examinations within a two-week period.
Who should consider this trial
Good fit: Ideal candidates are prostate cancer patients aged 18 to 90 with clinical suspicion of recurrence or newly diagnosed cases.
Not a fit: Patients with concurrent malignant tumors or significant liver and kidney dysfunction 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 management and treatment outcomes.
How similar studies have performed: Other studies have shown promise in using PET imaging agents for prostate cancer, but the specific comparison of these two agents 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 \[18F\]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.
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: +8613721108043
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.