European journal of nuclear medicine and molecular imaging · 2026
Tri-modal PSMA PET/CT-MRI-US fusion biopsy for clinically significant prostate cancer: a prospective paired diagnostic study.
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Huang Chen, Jin Lichen, Sun Yizhang, Wu Menglin, Zhang Xuefeng, Xu Xiaofeng, He Xuefeng, Qiu Feng, Wang Ximing, Guo Lingchuan, Huang Renpeng, Li Jihui, Deng Shengming, Lin Yuxin, Wei Xuedong, Zhang Bin, Huang Yuhua
Аннотация
PURPOSE: Multiparametric MRI (mpMRI)-ultrasound (US) fusion biopsy misses 8%-20% of clinically significant prostate cancer (csPCa), leaving a detection gap that prostate-specific membrane antigen (PSMA) PET/CT may help close. Whether incorporating PSMA into an MRI-US fusion platform improves csPCa detection has not been evaluated in a prospective paired design. We compared tri-modal PSMA PET/CT-MRI-US fusion biopsy with MRI-US fusion biopsy and systematic biopsy.
METHODS: In this prospective, single-center, and paired diagnostic accuracy study (STARD 2015; ChiCTR2400089436), 308 biopsy-naive men underwent tri-modal fusion biopsy, MRI-US fusion biopsy, and systematic biopsy in a single session. The primary endpoint was the absolute difference in patient-level csPCa detection (International Society of Urological Pathology grade group ≥ 2) between tri-modal and MRI-US fusion biopsies.
RESULTS: Tri-modal fusion detected 4.9% more csPCa than MRI-US fusion biopsy (95% confidence interval 2.4%-7.3%; P < 0.001; number needed to biopsy 20.5). The most significant gains were observed for PSMA-positive lesions < 10 mm (8.3%) and Prostate Imaging Reporting and Data System (PI-RADS) 4 lesions (5.8%), and this benefit persisted in multivariate generalized estimating equation models. The PSMA imaging-based risk score (area under the curve, 0.933) showed higher discrimination than the PRIMARY and molecular imaging PSMA scores. In a retrospective simulation using the test set, a risk-guided approach would have avoided approximately 42% of biopsies while missing 2.3% of csPCa. Limitations include the single-center design and the small test set.
CONCLUSION: Tri-modal fusion was superior to MRI-US fusion biopsy in detecting csPCa, particularly in small PSMA-positive and PI-RADS 4 lesions. A PSMA-derived risk score enabled effective stratification, and in the test set, a simulated risk-guided approach showed potential for biopsy reduction. These findings require multicenter validation before clinical adoption.
TRIAL REGISTRATION: ChiCTR2400089436 (Chinese Clinical Trial Registry, http://www.chictr.org.cn/ , registered 2024-09-09).
METHODS: In this prospective, single-center, and paired diagnostic accuracy study (STARD 2015; ChiCTR2400089436), 308 biopsy-naive men underwent tri-modal fusion biopsy, MRI-US fusion biopsy, and systematic biopsy in a single session. The primary endpoint was the absolute difference in patient-level csPCa detection (International Society of Urological Pathology grade group ≥ 2) between tri-modal and MRI-US fusion biopsies.
RESULTS: Tri-modal fusion detected 4.9% more csPCa than MRI-US fusion biopsy (95% confidence interval 2.4%-7.3%; P < 0.001; number needed to biopsy 20.5). The most significant gains were observed for PSMA-positive lesions < 10 mm (8.3%) and Prostate Imaging Reporting and Data System (PI-RADS) 4 lesions (5.8%), and this benefit persisted in multivariate generalized estimating equation models. The PSMA imaging-based risk score (area under the curve, 0.933) showed higher discrimination than the PRIMARY and molecular imaging PSMA scores. In a retrospective simulation using the test set, a risk-guided approach would have avoided approximately 42% of biopsies while missing 2.3% of csPCa. Limitations include the single-center design and the small test set.
CONCLUSION: Tri-modal fusion was superior to MRI-US fusion biopsy in detecting csPCa, particularly in small PSMA-positive and PI-RADS 4 lesions. A PSMA-derived risk score enabled effective stratification, and in the test set, a simulated risk-guided approach showed potential for biopsy reduction. These findings require multicenter validation before clinical adoption.
TRIAL REGISTRATION: ChiCTR2400089436 (Chinese Clinical Trial Registry, http://www.chictr.org.cn/ , registered 2024-09-09).