68Ga-PSMA-CYC PET imaging for diagnosing, staging, and restaging prostate cancer
Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer
This trial will test a new PET tracer called 68Ga-PSMA-CYC to see if it safely finds and stages prostate cancer in men and how it compares with current PSMA tracers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07056790 on ClinicalTrials.gov |
What this trial studies
This phase 1/2 interventional study gives men with confirmed prostate cancer a PET/CT scan with the novel tracer 68Ga-PSMA-CYC to record safety, whole-body biodistribution, and radiation dosimetry. Participants will also undergo head-to-head imaging comparisons with the established tracers 68Ga-PSMA-617 and 68Ga-PSMA-11 to compare lesion detection and image quality. The trial is prospective and conducted at a single site with informed consent required. Key outcomes include adverse events, organ radiation doses, and diagnostic performance versus the comparator tracers.
Who should consider this trial
Good fit: Men with confirmed prostate cancer (treated or untreated) who can give written informed consent and are able to undergo PET/CT scanning are eligible.
Not a fit: Patients with a known allergy to PSMA, those with medical conditions that prevent study participation, or those whose tumors do not express PSMA may not receive benefit from this imaging approach.
Why it matters
Potential benefit: If successful, the tracer could provide safer or more accurate PSMA-targeted PET imaging to improve detection and staging of prostate cancer.
How similar studies have performed: Other 68Ga-labeled PSMA tracers such as PSMA-11 and PSMA-617 have been widely used and shown high accuracy for detecting prostate cancer, so this approach builds on established, successful methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * confirmed treated or untreated prostate cancer patients; * signed written consent. Exclusion Criteria: * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Where this trial is running
Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Weibing Miao, MD — First Affiliated Hospital of Fujian Medical University
- Study coordinator: Weibing Miao, MD
- Email: miaoweibing@126.com
- Phone: 059187981618
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.