Comparing two PET imaging methods for prostate cancer detection
A Pilot Comparison of 68Ga-P16-093 and 68Ga-PSMA-11 in the Same Group of Primary Prostate Cancer Patients
This study is testing a new imaging method for prostate cancer to see if it can find cancer better than the current standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05324332 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the diagnostic performance of a novel radiopharmaceutical, 68Ga-P16-093, against the widely used 68Ga-PSMA-11 in detecting primary prostate cancer and its metastases. Both imaging methods will be administered to the same group of patients within a week to assess their sensitivity and specificity. The study aims to improve the detection of prostate cancer lesions that may not be visible through traditional imaging techniques like CT or MRI. By utilizing advanced PSMA-targeted PET imaging, the study seeks to enhance diagnostic accuracy for prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed untreated primary prostate cancer.
Not a fit: Patients with known allergies to PSMA or those with medical conditions that may interfere with study compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection rates of prostate cancer, allowing for earlier and more effective treatment options.
How similar studies have performed: Previous studies have shown promising results with PSMA-targeted imaging, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed untreated primary prostate cancer patients; * 68Ga-PSMA-11 and 68Ga-P16-093 PET/CT within a week; * 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
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhaohui Zhu, MD — Peking Union Medical College Hospital
- Study coordinator: Zhaohui Zhu, MD
- Email: 13611093752@163.com
- Phone: 86-13611093752
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.