New PSMA PET scan (68Ga-P16-093) versus mpMRI to locate prostate cancer
68Ga-P16-093 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI
This trial will test whether a new PSMA PET scan (68Ga-P16-093) finds and localizes prostate cancer better than the standard mpMRI in men newly diagnosed who have not yet received treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07209865 on ClinicalTrials.gov |
What this trial studies
This study uses the novel PSMA-targeting radiotracer 68Ga-P16-093 with PET/CT or PET/MRI and directly compares the imaging results to multi-parametric MRI in men with newly diagnosed, treatment-naive prostate adenocarcinoma. Participants undergo the PET exam and mpMRI before a scheduled radical prostatectomy, allowing surgical pathology to serve as the reference standard for lesion detection and localization. The protocol builds on prior clinical work with 68Ga-P16-093 PET/CT and aims for a head-to-head performance comparison against the current imaging standard. Imaging accuracy, lesion concordance, and localization relative to pathology will be the main outcomes.
Who should consider this trial
Good fit: Men with biopsy-confirmed prostate adenocarcinoma who have not received any anti-tumor treatment and who are scheduled for radical prostatectomy within about 28 days may be eligible.
Not a fit: Patients with prior prostate cancer treatment, other active malignant tumors, or those not scheduled for prostatectomy (so no surgical pathology confirmation) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the new PSMA PET scan could improve detection and precise localization of prostate cancer, which may help guide surgery and treatment planning.
How similar studies have performed: Other PSMA-targeted PET agents have shown promising diagnostic performance and the investigators report prior clinical studies with 68Ga-P16-093 PET/CT, but mpMRI remains a well-established standard for local prostate imaging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy-confirmed adenocarcinoma of the prostate. * No anti-tumor treatment received prior to the PET imaging. * Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. * Radical prostatectomy scheduled within 28 days after PET imaging. Exclusion Criteria: * Patients with other malignant tumors * Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
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.