[Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with [Ga]Ga-PSMA-11.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
37 patients who underwent both [⁶⁸Ga]Ga-P16-093 and [Ga]Ga-PSMA-11 PET/CT was analyzed for direct comparison.
I · Intervention 중재 / 시술
[Ga]Ga-P16-093 PET imaging, and a subset also received [Ga]Ga-PSMA-11 PET/CT within one week
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Registered 04 March 2022. URL OF REGISTRY: https://clinicaltrials.gov/ct2/show/NCT05324332.
[PURPOSE] Prostate-specific membrane antigen (PSMA) PET/CT enhances prostate cancer (PCa) diagnosis.
- p-value P = 0.041
- p-value P = 0.037
- 95% CI 68.38-80.50
- Sensitivity 74.44%
- Specificity 96.26%
APA
Wang J, Li L, et al. (2026). [Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with [Ga]Ga-PSMA-11.. European journal of nuclear medicine and molecular imaging, 53(5), 3064-3073. https://doi.org/10.1007/s00259-025-07687-0
MLA
Wang J, et al.. "[Ga]Ga-P16-093 PET/CT in newly diagnosed prostate cancer: Histopathological validation and comparison with [Ga]Ga-PSMA-11.." European journal of nuclear medicine and molecular imaging, vol. 53, no. 5, 2026, pp. 3064-3073.
PMID
41366119 ↗
Abstract 한글 요약
[PURPOSE] Prostate-specific membrane antigen (PSMA) PET/CT enhances prostate cancer (PCa) diagnosis. The newly developed PSMA probe, [Ga]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 [Ga]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 [Ga]Ga-P16-093 PET imaging, and a subset also received [Ga]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 [Ga]Ga-P16-093 were statistically compared with that of [Ga]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 [Ga]Ga-PSMA-11 PET/CT was analyzed for direct comparison. [Ga]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 [Ga]Ga-PSMA-11 PET/CT, [Ga]Ga-P16-093 PET/CT showed higher tracer uptake, with SUV of 9.86 ± 6.82 vs. 6.74 ± 1.89 (P = 0.041), SUV 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 [Ga]Ga-PSMA-11 PET/CT.
[CONCLUSION] [Ga]Ga-P16-093 PET/CT exhibits high diagnostic performance in the diagnosis of primary PCa and shows significant advantages in identifying local tumor segments. [Ga]Ga-P16-093 may serve as an alternative to [Ga]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.
[METHODS] This prospective study enrolled newly diagnosed PCa patients (April 2022-November 2023). All patients underwent [Ga]Ga-P16-093 PET imaging, and a subset also received [Ga]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 [Ga]Ga-P16-093 were statistically compared with that of [Ga]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 [Ga]Ga-PSMA-11 PET/CT was analyzed for direct comparison. [Ga]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 [Ga]Ga-PSMA-11 PET/CT, [Ga]Ga-P16-093 PET/CT showed higher tracer uptake, with SUV of 9.86 ± 6.82 vs. 6.74 ± 1.89 (P = 0.041), SUV 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 [Ga]Ga-PSMA-11 PET/CT.
[CONCLUSION] [Ga]Ga-P16-093 PET/CT exhibits high diagnostic performance in the diagnosis of primary PCa and shows significant advantages in identifying local tumor segments. [Ga]Ga-P16-093 may serve as an alternative to [Ga]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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