Prostate cancer remains the most prevalent genitourinary malignancy among men worldwide. Early and accurate diagnosis is fundamental to comprehensive disease management, long-term survival improvement, and reduction of the societal burden of disease. As the pathological gold standard for prostate cancer diagnosis, biopsy continues to serve as the central arena for technological innovation and clinical investigation in precision oncology.In 2025, global advances in prostate biopsy were characterized by a clear transition from technological innovation to tangible clinical value, and from single-modality approaches to multimodal integration. Across four key domains—imaging guidance refinement, optimization of biopsy routes, streamlining of biopsy schemes, and construction of integrated diagnostic pathways—a total of 168 high-quality clinical studies and translational achievements were reported. These efforts are accelerating the evolution of precision biopsy from elite medicine to broadly accessible care.
Oncology Frontier – Urology News invited Prof. Xingkang Jiang from The Second Hospital of Tianjin Medical University and Prof. Yi Liu from Peking University First Hospital to provide this annual review. Drawing upon landmark publications in leading journals such as JAMA, The Lancet Oncology, and European Urology, updated CSCO and EAU guidelines, and major presentations at international meetings including EAU 2025, this review systematically summarizes key breakthroughs, clinical implications, and future research directions—offering practical, evidence-based guidance for clinical practice in China.
Imaging-Guided Innovation
High-Resolution Ultrasound Breakthroughs and Multimodal Precision Navigation
Imaging guidance remains the cornerstone for enhancing biopsy accuracy while balancing the risks of missed diagnosis and overdiagnosis. In 2025, the most landmark advance was the high-level validation of high-resolution micro-ultrasound (Micro-US), whose complementary integration with multiparametric MRI (mpMRI) has reshaped the previously MRI-dominated paradigm. Clinical exploration of 5T MRI and the maturation of AI-assisted image interpretation further strengthened individualized precision guidance strategies adaptable to different healthcare resource settings.
1. Micro-Ultrasound–Guided Biopsy: A High-Value, Cost-Effective Emerging Standard
The international multicenter OPTIMUM randomized controlled trial led by Laurence Klotz from the University of Toronto (published in JAMA and presented at EAU 2025) represents a landmark contribution. Enrolling over 800 patients across 20 centers in eight countries, the trial compared mpMRI-guided biopsy, Micro-US–guided biopsy, and combined Micro-US + mpMRI guidance.
Results demonstrated no significant difference in overall prostate cancer detection rates among the three groups. However, Micro-US achieved a 4% higher detection rate of clinically significant prostate cancer (csPCa; Gleason ≥3+4) compared with mpMRI and identified over 90% of high-risk lesions (PMID: 40121537).
Technically, Micro-US utilizes high-frequency imaging that delivers threefold greater resolution than conventional transrectal ultrasound, enabling detailed visualization of subtle lesions in both the peripheral and transition zones. Clinically, it offers three key advantages:
- No requirement for gadolinium contrast, avoiding nephrotoxicity risks.
- Equipment and procedural costs approximately one-third to one-half of mpMRI, allowing same-visit imaging and biopsy.
- Independent interpretation and operation achievable after 2–4 weeks of standardized training, substantially improving accessibility in primary and resource-limited settings.
Importantly, integration of Micro-US with AI is entering early clinical application. Preliminary single-center studies suggest that AI-assisted lesion recognition improves detection efficiency by 30% and reduces subjective variability, supporting broader implementation.
2. Multimodal Fusion: From Lesion Targeting to End-to-End Decision Support
In 2025, MRI–ultrasound fusion-guided biopsy matured into a comprehensive decision-support platform extending beyond lesion targeting to encompass pre-biopsy risk stratification, trajectory planning, pathological validation, and surveillance monitoring.
The 2025 CSCO Prostate Cancer Guidelines upgraded mpMRI from an optional to a mandatory pre-biopsy examination. Patients with PI-RADS ≥3 lesions are recommended to undergo MRI–ultrasound fusion-targeted biopsy. Compared with systematic biopsy alone, fusion guidance increases csPCa detection by 27% while reducing clinically insignificant cancer detection by 18% (Kasivisvanathan et al., 2025; PMID: 39232979).
A multicenter longitudinal study led by Hamm (published in JAMA Oncology) demonstrated the oncologic safety of deferring biopsy in mpMRI-negative patients. Among 593 men aged 18–75 years, 44% avoided immediate biopsy, and 41% remained biopsy-free at 3 years, with no increase in csPCa incidence (PMID: 39666360).
Emerging imaging technologies further expanded diagnostic capabilities:
- PSMA-PET/MRI demonstrated strong negative predictive value, particularly in younger patients.
- 5T MRI showed superior image quality and detection of micro-lesions compared with 3T MRI (PMID: 41559204).
- The RAPID trial led by Hartenbach confirmed that PSMA-targeted PET/MRI reduces unnecessary biopsies by 35% in men with moderately elevated PSA (PMID: 41266255).
AI-assisted fusion diagnostics also made notable progress. A multicenter study from Beijing Friendship Hospital validated GPT-4–assisted biopsy decision-making, demonstrating that 20.8% of intermediate-risk patients could avoid unnecessary biopsy with 82.8% prediction accuracy (PMID: 40619425). Zero-shot PI-RADS scoring by ChatGPT-4 Turbo and Llama 3 achieved >85% agreement with radiologists (PMID: 41347921), accelerating translational implementation.
Optimization of Biopsy Route and Strategy
Safety-Centered, Needle-Reduction Paradigm
In 2025, the optimization of biopsy strategies centered on safety, efficiency, and minimal invasiveness. Two dominant trends emerged: widespread adoption of the transperineal (TP) approach and evidence-based reduction in systematic core numbers.
1. Transperineal Biopsy: The Preferred Approach for Infection Risk Reduction
Rising fluoroquinolone-resistant Escherichia coli (global resistance ~38%) has heightened concern over infection following transrectal biopsy (TR-Bx). The transperineal approach (TP-Bx), which avoids rectal flora contamination, demonstrated infection rates below 0.5% and gained global acceptance.
The TRANSLATE randomized trial published in The Lancet Oncology showed that TP-Bx under local anesthesia increased csPCa detection by 5% and reduced severe infection by 82% compared with TR-Bx (PMID: 40139210). Meta-analysis of 23 RCTs further confirmed superior anterior lesion detection and comparable minor complication rates (PMID: 41551330).
Expert consensus published in European Urology in 2026 established antibiotic-free transperineal biopsy as a new clinical standard (PMID: 41136277). Chinese real-world data corroborated these findings, with TP utilization increasing from 12% in 2015 to 78% in 2025.
2. Needle Reduction: High-Efficiency Biopsy in the Precision Era
Traditional 12–14-core systematic biopsy is increasingly replaced by “targeted + streamlined systematic” strategies.
The VISION meta-analysis (PMID: 39232979) demonstrated that MRI-targeted biopsy increases csPCa detection by 8.7% while reducing detection of insignificant disease by 12.3%.
The SEXTANT-PRO non-inferiority RCT led by Prof. Kan Gong and Prof. Yi Liu (published in eClinicalMedicine) compared “targeted + 6-core” versus “targeted + 12-core” strategies in 506 patients. Detection rates of csPCa were equivalent (54.3% vs. 54.8%), while the 6-core approach reduced procedure time by 30%, pain by 25%, and bleeding complications by 18% (PMID: 41324010).
Additional refinements—such as sampling within 1 cm of suspicious lesions—further reduced missed micro-csPCa without increasing procedural burden (PMID: 40760321).
Integrated Diagnostic Pathway
Molecular and Imaging Fusion to Avoid Unnecessary Biopsy
Biopsy optimization now spans the entire care continuum—from pre-biopsy risk assessment to post-biopsy staging and surveillance.
The 2025 CSCO Guidelines newly recommend 4Kscore and Prostate Health Index (PHI) for risk stratification in PSA gray-zone patients (4–10 ng/mL). Combined 4Kscore + PHI improved positive predictive value from 28% to 45% and negative predictive value to 92% (PMID: 41107473).
Emerging biomarkers, including methylation-based four-gene panels (AUC 0.89 vs. PSA 0.62; PMID: 40804569) and rapid urine PSA–zinc assays (PMID: 41354696), further improved diagnostic precision.
PSMA-PET/CT was recommended for initial staging of high-risk localized disease, significantly improving detection of sub-centimeter nodal metastases (PMID: 41266255). Multigene risk scores (BARCODE1 study; PMID: 40214032) and metabolomic signatures (PMID: 39383254) enhanced surveillance biopsy stratification.
Clinical Translation and Future Directions
Intelligence, Minimally Invasive Approaches, and Localization
Key advances in 2025 reflect alignment between innovation and clinical needs: improving diagnostic precision, enhancing safety, reducing burden, and increasing accessibility.
Future research will focus on three major directions:
- Deep integration of AI and imaging, including non-rigid MR–TRUS registration and AI-assisted digital pathology (PMID: 41520474; 41094148).
- Robotic-assisted precision biopsy, such as the ProBot ultrasound system with <1 mm targeting error (PMID: 40779386).
- Localization strategies for Chinese populations, optimizing transperineal pathways and transition-zone–focused protocols.
Conclusion
Advances in prostate biopsy in 2025 mark the arrival of a new era characterized by precision, safety, efficiency, and accessibility. With ongoing technological innovation and clinical validation, biopsy will continue to serve as the pivotal hub in comprehensive prostate cancer management, providing a strong foundation for improved long-term patient outcomes.
Prof. Xingkang Jiang
Prof. Yi Liu
