68Ga-PSMA-CYC PET imaging for diagnosing, staging, and restaging prostate cancer
Official title: Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer
Run by First Affiliated Hospital of Fujian Medical University · NCT07056790 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | Men only |
| Enrollment | 40 (estimated) |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Fuzhou, Fujian) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | February 2027 |
| Study ends | May 2027 |
| Registry record updated | July 9, 2025 |
| Trial ID | NCT07056790 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.