Clinical trial · Interventional
68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients
A Pilot Comparison of 68Ga-P16-093 and 68Ga-PSMA-11 in the Same Group of Primary Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the most widely studied 68Ga-PSMA-11. This pilot study was evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-11 in the same group of primary prostate cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-P16-093 | Drug | — | UNRESOLVED |
| 68Ga-PSMA-11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-P16-093 and 68Ga-PSMA-11 PET/ CT scan
- description
- Patients of Prostate cancer PET/CT imaging: In two consecutive days, each patient underwent whole-body PET/CT scan after intravenous administration of 68Ga-P16-093 and 68Ga-PSMA-11, respectively.
- interventionNames
- Drug: 68Ga-P16-093
- Drug: 68Ga-PSMA-11
Primary outcomes (1)
- measure
- Tumor detection rate
- timeFrame
- through study completion, an average of 1 year
- description
- comparing the number of tumor detected by 68Ga-P16-093 and 68Ga-PSMA-11 PET/CT
Secondary outcomes (1)
- measure
- standardized uptake value (SUV) of tumor
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDWang J, Li L, Chen J, Wang R, Xiang J, Peng X, Wang Y, Luo Y, Zhu L, Kung HF, Zhou Z, Xiao Y, Zhu Z. [68Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with [68Ga]Ga-PSMA-11. Eur J Nucl Med Mol Imaging. 2026 Apr;53(5):3064-3073. doi: 10.1007/s00259-025-07687-0. Epub 2025 Dec 10. PMID 41366119
- DERIVEDWang G, Li L, Zhu M, Zang J, Wang J, Wang R, Yan W, Zhu L, Kung HF, Zhu Z. A prospective head-to-head comparison of [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11 PET/CT in patients with primary prostate cancer. Eur J Nucl Med Mol Imaging. 2023 Aug;50(10):3126-3136. doi: 10.1007/s00259-023-06283-4. Epub 2023 May 26. PMID 37233785