Tri-modal PSMA PET/CT-MRI-US fusion biopsy for clinically significant prostate cancer: a prospective paired diagnostic study
6 affiliations
- 1Department of Urology, The First Affiliated Hospital of Soochow University, 899 Pinghai Road, Suzhou, 215006 China
- 2School of Computer Science and Technology, Nanjing Tech University, Nanjing, 211816 China
- 3Carbon Medical Device Ltd, Shenzhen, China
- 4Department of Radiology, The First Affiliated Hospital of Soochow University, Suzhou, 215006 China
- 5Department of Pathology, The First Affiliated Hospital of Soochow University, Suzhou, 215006 China
- 6Department of Nuclear Medicine, The First Affiliated Hospital of Soochow University, 899 Pinghai Road, Suzhou, 215006 China
Abstract
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).
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00259-026-08181-x.
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BibTeX
@article{huang2026trimodal,
title = {{Tri-modal PSMA PET/CT-MRI-US fusion biopsy for clinically significant prostate cancer: a prospective paired diagnostic study}},
author = {Chen Huang and Lichen Jin and Yizhang Sun and Menglin Wu and Xuefeng Zhang and Xiaofeng Xu and Xuefeng He and Feng Qiu and Ximing Wang and Lingchuan Guo and Renpeng Huang and Jihui Li and Shengming Deng and Yuxin Lin and Xuedong Wei and Bin Zhang and Yuhua Huang},
journal = {European Journal of Nuclear Medicine and Molecular Imaging},
year = {2026},
month = sep,
doi = {10.1007/s00259-026-08181-x},
url = {https://doi.org/10.1007/s00259-026-08181-x},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Tri-modal PSMA PET/CT-MRI-US fusion biopsy for clinically significant prostate cancer: a prospective paired diagnostic study
AU - Chen Huang
AU - Lichen Jin
AU - Yizhang Sun
AU - Menglin Wu
AU - Xuefeng Zhang
AU - Xiaofeng Xu
AU - Xuefeng He
AU - Feng Qiu
AU - Ximing Wang
AU - Lingchuan Guo
AU - Renpeng Huang
AU - Jihui Li
AU - Shengming Deng
AU - Yuxin Lin
AU - Xuedong Wei
AU - Bin Zhang
AU - Yuhua Huang
PY - 2026
DA - 2026/09/15
JO - European Journal of Nuclear Medicine and Molecular Imaging
DO - 10.1007/s00259-026-08181-x
UR - https://doi.org/10.1007/s00259-026-08181-x
AB - 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). Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00259-026-08181-x.
SN - 1619-7070
SN - 1619-7089
ER -