GRPR PET imaging for diagnosis and staging of prostate cancer
The Value of Gastrin-Releasing Peptide Receptor (GRPR) PET Imaging for Diagnosis and Staging in Prostate Cancer
This will test two new GRPR PET tracers (68Ga-G21 and 68Ga-G23) alongside 68Ga-PSMA-11 to see if they better detect and stage prostate cancer in men with confirmed disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07363382 on ClinicalTrials.gov |
What this trial studies
This interventional Phase 1/2 imaging study enrolls men with confirmed prostate adenocarcinoma to undergo PET imaging with two novel GRPR-targeting tracers, 68Ga-G21 and 68Ga-G23, and comparison imaging with 68Ga-PSMA-11. Investigators will document tracer biodistribution, safety, and lesion detection across initial staging, biochemical recurrence, and metastatic disease settings. Imaging results will be compared to determine concordance, added lesion detection, and potential complementarity where PSMA expression is low or negative. The protocol focuses on quantifying diagnostic performance and informing whether GRPR PET can guide clinical management in cases where PSMA PET is insufficient.
Who should consider this trial
Good fit: Men with confirmed treated or untreated prostate adenocarcinoma who can provide informed consent, especially those with intermediate or high-risk disease or suspected biochemical recurrence, are ideal candidates.
Not a fit: Patients with a known allergy to PSMA radiopharmaceuticals, significant medical issues that prevent study participation, or tumors with low GRPR expression are unlikely to benefit.
Why it matters
Potential benefit: If successful, these GRPR tracers could detect cancers that PSMA PET misses and improve staging and treatment decisions for affected patients.
How similar studies have performed: Multiple prior studies have reported promising results for GRPR PET as a complementary imaging tool to PSMA PET, though larger head-to-head comparisons remain limited.
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
- Department of Nuclear Medicine, 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: 86-0591-87981618
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.