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Updated: May 2, 2026
MR Molecular Imaging of Prostate Cancer with a Small Molecular CLT1 Peptide Targeted Contrast Agent
Published on: September 3, 2013
[68Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with
Jiarou Wang1, Linlin Li2, Jingci Chen3
1Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, State Key Laboratory of Complex Severe and Rare Diseases, Beijing Key Laboratory of Molecular Targeted Diagnosis and Therapy in Nuclear Medicine, Beijing, 100730, China.
Purpose:
Prostate-specific membrane antigen (PSMA) PET/CT enhances prostate cancer (PCa) diagnosis. The newly developed PSMA probe, [68Ga]Ga-P16-093, with low urinary excretion, has shown superior diagnostic efficacy compared to conventional PSMA probes. This study aims to assess the diagnostic efficacy and local-regional staging performance of [68Ga]Ga-P16-093 in PCa lesions of newly diagnosed patients, using histopathology as the gold standard for validation.
Methods:
This prospective study enrolled newly diagnosed PCa patients (April 2022-November 2023). All patients underwent [68Ga]Ga-P16-093 PET imaging, and a subset also received [68Ga]Ga-PSMA-11 PET/CT within one week. Radical prostatectomy within two weeks post-PET provided complete pathological specimens from all patients. The diagnostic efficacy and locoregional staging performance of [68Ga]Ga-P16-093 were statistically compared with that of [68Ga]Ga-PSMA-11, using histopathology as the gold standard.
Results:
Fifty-six treatment-naïve male patients (mean age 67 ± 6 years; range 52-77) were prospectively enrolled. A subgroup of 37 patients who underwent both [⁶⁸Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11 PET/CT was analyzed for direct comparison. [68Ga]Ga-P16-093 PET/CT demonstrated superior diagnostic performance in primary prostate cancer evaluation, with sensitivity of 74.44% (201/270, 95% CI: 68.38-80.50%), specificity of 96.26% (387/402, 95% CI: 94.39-98.15%), and accuracy of 87.50% (588/672, 95% CI: 85.05-89.95%). Compared with [68Ga]Ga-PSMA-11 PET/CT, [68Ga]Ga-P16-093 PET/CT showed higher tracer uptake, with SUVmax of 9.86 ± 6.82 vs. 6.74 ± 1.89 (P = 0.041), SUVmean of 5.81 ± 4.03 vs. 3.98 ± 1.04 (P = 0.037), and T/B ratio of 23.19 ± 17.51 vs. 16.04 ± 7.75 (P = 0.042). Additionally, ROC analysis revealed a significantly greater AUC for P16-093 (0.85 vs. 0.75, P < 0.05). Moreover, locoregional staging accuracy was higher at 59.46% (22/37) compared with 32.43% (12/37) for [68Ga]Ga-PSMA-11 PET/CT.
Conclusion:
[68Ga]Ga-P16-093 PET/CT exhibits high diagnostic performance in the diagnosis of primary PCa and shows significant advantages in identifying local tumor segments. [68Ga]Ga-P16-093 may serve as an alternative to [68Ga]Ga-PSMA-11 in the future diagnosis of PCa.
Trial Registration:
ClinicalTrials.gov, NCT05324332. Registered 04 March 2022. URL OF REGISTRY: https://clinicaltrials.gov/ct2/show/NCT05324332.
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