EAU 2025 | Optimizing Prostate Biopsy Approaches: Prof. Kan Gong's Team's Peri-lesion Biopsy RCT Study Awarded at EAU

At the 40th Annual European Association of Urology (EAU) Congress, precision biopsy strategies and technological innovation were core topics in the prostate cancer field. With a focus on addressing the limitations of traditional systematic biopsies and MRI-targeted biopsies, multiple studies concentrated on optimizing biopsy approaches to balance diagnostic efficacy and safety. "UroStream" invited Professors Kan Gong and Yi Liu from Peking University First Hospital, along with Dr. Ruiyi Deng, to discuss the latest advancements in prostate cancer biopsy at the EAU conference, their team’s peri-lesion biopsy RCT study findings, and cutting-edge precision biopsy approaches.

Prof. Kan Gong: We know that early screening, diagnosis, and treatment of prostate cancer play a significant role in improving patient prognosis. Among these, prostate biopsy remains a key diagnostic tool that is indispensable for diagnosing prostate cancer. Depending on the patient, different biopsy strategies (systematic, targeted, etc.) and methods (transperineal or transrectal) may need to be selected. Dr. Ruiyi Deng, could you share with us the progress made in prostate cancer biopsy strategies and methods at this year’s EAU conference?

Dr. Ruiyi Deng: Prostate biopsy has long been an essential method for diagnosing prostate cancer. In the past, before imaging technologies were widely available, systematic biopsy was the primary diagnostic tool. With the continuous advancement of imaging technologies such as MRI, targeted biopsies and more precise diagnostic methods have gradually emerged and been widely applied. Recently, with the deepening of imaging diagnostics and personalized precision diagnostic concepts, strategies such as peri-lesion biopsies have become new research hotspots.

Currently, prostate biopsy is primarily conducted using two methods: transperineal biopsy and transrectal biopsy. Previous research has shown that both biopsy methods have comparable overall diagnostic efficacy for prostate cancer and clinically significant prostate cancer. At this year’s EAU conference, prostate biopsy strategies and methods were hot topics of discussion. The conference focused on in-depth discussions regarding MRI-targeted, systematic, and peri-lesion biopsy strategies, with several studies comparing different biopsy approaches.

Dr. Amusat O. and his team from Bedfordshire NHS Foundation Trust, UK, shared a study validating the EAU transperineal prostate biopsy risk stratification table (A0744). This study analyzed 1,054 patients who underwent cognitive fusion transperineal prostate biopsy under local anesthesia. The detection rate of clinically significant prostate cancer (csPCa) in this study was 44.9%. The authors focused on patients with PIRADS 4 & 5 lesions who had prostate lesions suitable for targeted biopsy, and found that if only targeted biopsy was performed, 12.1% of csPCa cases might be missed. This suggests that relying solely on targeted biopsy does not provide sufficient diagnostic efficacy, and a combination with systematic biopsy or other biopsy methods is still necessary.

Additionally, Professor Zhao Jiafeng’s team from the University of Hong Kong presented the results of a multicenter randomized controlled clinical trial (A0746). The study included 502 patients with elevated PSA (4-20 ng/ml). The research compared MRI-targeted biopsy plus 12-core systematic biopsy with 24-core transperineal systematic biopsy. The csPCa detection rate for the MRI-TB group was 25.1%, and for the 24-core SB group, it was 29.0%, with no significant difference between the two groups. However, the detection rate for clinically insignificant prostate cancer (ISUP Grade 1) was significantly higher in the 24-core SB group (16.4%) compared to the MRI-TB group (9.2%), suggesting that the 24-core transperineal systematic biopsy may lead to overdiagnosis. Furthermore, the MRI-TB group reduced unnecessary biopsy needles by 45%, and the incidence of adverse events and complications was significantly lower in the MRI-TB group compared to the 24-core SB group (25.1% vs 44.1%).

Currently, the combination of targeted biopsy and peri-lesional biopsy is recommended in the 2024 EAU guidelines for patients with suspicious lesions detected by prostate MRI. A retrospective study from the IRCCS San Raffaele Scientific Institute in Italy, led by Dr. Quarta L., included 3,006 patients with multiparametric MRI-positive (PIRADS ≥3) who underwent systematic combined targeted biopsy. The study used all systematic combined targeted biopsy pathology results as the reference standard and defined the peri-lesional biopsy site as the area within the suspicious prostate lesion. The goal was to compare the diagnostic efficacy and added value of peri-lesional biopsy versus systematic biopsy for patients with different PIRADS scores.

The overall detection rates for csPCa and PCa in this study were 48% and 66%, respectively. The researchers found that in patients with PIRADS 4 and 5, peri-lesional biopsy combined with targeted biopsy achieved diagnostic efficacy similar to that of systematic combined targeted biopsy (csPCa detection rate: PIRADS 4: 50% vs 53%, PIRADS 5: 75% vs 76%). However, for PIRADS 3 patients, the csPCa detection rate with peri-lesional biopsy combined with targeted biopsy was significantly lower than that with systematic combined targeted biopsy (21% vs 25%, P=0.02). This suggests that when selecting biopsy strategies for different patients, decisions should be stratified based on PIRADS scores. The combination of peri-lesional biopsy and targeted biopsy in PIRADS 3 patients still requires further research for validation.

Prof. Kan Gong: While mpMRI can help identify suspicious lesions, it often underestimates the actual extent of tumor infiltration, which poses a risk of missed diagnoses with targeted biopsy alone. On the other hand, combining systematic biopsy with targeted biopsy increases the risk of overdiagnosis. A combined approach of targeted biopsy and peri-lesional biopsy holds promise in improving diagnostic accuracy for prostate cancer while balancing the risks of overdiagnosis and underdiagnosis. Our recent study in this area was selected for presentation at the EAU Congress and was honored with the second prize in the Best Abstracts by Residents-in-Urology Awards, which greatly encourages us to continue our research. Dr. Ruiyi Deng, on behalf of our urologic oncology team at Peking University, presented the study. I’ll let Dr. Deng share the main findings of this work.

Dr. Ruiyi Deng: At this year’s EAU Congress, I presented a randomized controlled trial (RCT) comparing peri-lesional plus targeted biopsy with the standard combined systematic and targeted biopsy. Traditionally, international guidelines recommend combined targeted and systematic biopsy (CTSBx) for patients with suspicious lesions on prostate MRI. While CTSBx offers strong diagnostic performance for clinically significant prostate cancer (csPCa), it involves a relatively high number of biopsy cores—often 15 to 20—which increases the risks of overdiagnosis and post-biopsy complications.

With advancements in imaging and personalized diagnostics, the urological community has been actively exploring biopsy optimization strategies. These include local saturation biopsy, peri-lesional biopsy, modified sextant biopsy, and reduced-core systematic biopsy. Among these, peri-lesional biopsy has emerged as a hot topic.

The theoretical foundation for this approach comes from a 2022 article published in European Urology, which found that ~90% of csPCa cases are located within a 10 mm radius of MRI-visible lesions. Based on this insight, the peri-lesional biopsy approach focuses biopsy cores around the suspicious MRI lesions to improve csPCa detection. In recent years, several studies have supported this strategy, and the 2024 EAU Guidelines now recommend targeted plus peri-lesional biopsy (TPLBx) for patients with PIRADS ≥4 and select PIRADS 3 lesions. However, most existing evidence is retrospective, and the strength of recommendation remains weak in both the 2024 and upcoming 2025 EAU guidelines. Thus, high-quality, prospective evidence is urgently needed.

To address this gap, we conducted an RCT comparing TPLBx and CTSBx. A total of 343 patients were enrolled and randomly assigned to the TPLBx group (n=170; 3 targeted cores + 6 peri-lesional cores within 10–15 mm of the lesion) or the CTSBx group (n=173; 3 targeted cores + 12 systematic cores). The primary endpoint was csPCa detection rate.

The results showed comparable diagnostic efficacy between the two groups (csPCa: 57.6% vs. 56.1%; PCa: 64.1% vs. 64.2%; P > 0.05). Notably, the TPLBx group required fewer biopsy cores (9 vs. 15) and had significantly shorter procedure times (P < 0.05). During follow-up, patients in the TPLBx group also experienced significantly fewer complications, especially bleeding-related events such as hematuria, hematochezia, and localized bleeding (P < 0.05). Additionally, TPLBx was associated with less procedural pain and discomfort.

In conclusion, our RCT demonstrates that TPLBx offers diagnostic accuracy comparable to CTSBx, while significantly reducing the number of biopsy cores, procedure time, and complication rates. As the world’s first RCT to comprehensively evaluate the diagnostic performance and safety of targeted plus peri-lesional biopsy, our study provides high-level clinical evidence for optimizing prostate cancer diagnostic strategies and advancing personalized care.

This study received the Best Abstracts by Residents-in-Urology Award from the EAU and was the only winning entry from China. Dr. Juan Luis Vásquez, Chair of the EAU Young Urologists Office, praised the study’s value and clinical significance: “We look forward to seeing more high-quality clinical data from China and hearing more voices from Peking University Urology Institute on the international stage. This is a powerful contribution of Chinese wisdom to global urology.”

Prof. Kan Gong: Our research is gradually moving toward the concept of “precision biopsy,” which is also the current focus in the field. Precision biopsy integrates imaging, molecular diagnostics, and artificial intelligence to improve early detection rates, minimize missed diagnoses, and avoid unnecessary biopsy-related trauma. Dr. Deng, could you share some of the key discussion points from the congress?

Dr. Ruiyi Deng: Precision diagnosis of prostate cancer has become a major topic in medical research in recent years. With the rapid development of imaging, molecular diagnostics, and artificial intelligence (AI), the field has seen a wave of innovation—particularly in prostate MRI, PSMA PET/CT, and various molecular probes. AI has also become a powerful tool to enhance diagnostic accuracy.

At our center, we collaborated with the Department of Radiology at Peking University First Hospital to develop an AI-assisted diagnostic model for prostate imaging. We also explored a new AI-assisted method for cognitive fusion-targeted prostate biopsy. Through randomized controlled trials, we demonstrated that this AI-assisted approach offers greater accuracy in detecting clinically significant prostate cancer (csPCa) compared to traditional biopsy techniques. Looking ahead, AI, combined with molecular diagnostics, imaging, and pathology, will continue to elevate the precision of prostate cancer diagnosis.

At this year’s EAU Congress, many studies focused on various aspects of precision diagnostics, including biopsy techniques and accurate pathological assessment after radical prostatectomy. One standout example was a late-breaking abstract from Prof. Mayor N. and colleagues at Imperial College London, which explored a novel technique for assessing surgical margins in prostatectomy specimens.

Traditionally, evaluating the surgical margins of radical prostatectomy specimens requires considerable cost and manpower. This study introduced the use of fluorescence confocal microscopy (FCM) to rapidly assess the margins. Compared to conventional histopathology, FCM offers faster imaging and greater efficiency, although its diagnostic performance still requires further validation.

This multicenter, prospective, paired-cohort study enrolled 156 patients undergoing radical prostatectomy for primary prostate cancer across all risk levels. The surgeries were performed by seven surgeons with a median of 16 years’ experience. The prostate specimens were scanned using FCM, and standard histopathological analysis was then conducted. Two independent uropathologists—blinded to the histological results—reviewed the FCM images. The study’s primary endpoint was the sensitivity of FCM for detecting positive surgical margins (PSMs), aiming for a sensitivity benchmark of 85% ±10%.

Among the 156 patients, 22 (14.1%) were classified as EAU intermediate-risk, 101 (64.7%) as high-risk, and 33 (21.2%) as locally advanced. T3 stage was observed in 33 patients (21.2%). Histopathology identified positive surgical margins in 30.8% (48/156) of cases. Although FCM did not meet the predefined sensitivity threshold for all margins (85% ±10%), it demonstrated promising diagnostic accuracy (AUC 0.80; 95% CI: 0.73–0.86) and high specificity (0.94; 95% CI: 0.88–0.98). When stratified by margin length, FCM showed better sensitivity for detecting margins ≥4 mm (0.83; 95% CI: 0.59–0.96).

In summary, this study indicates that FCM is a promising tool for detecting surgical margins ≥4 mm in prostatectomy specimens, though conventional histopathology remains necessary for margins ≤4 mm. As a representative of new diagnostic technologies, this work exemplifies how innovations in imaging, molecular diagnostics, and AI will continue to drive the advancement of precision diagnostics in prostate cancer.

We look forward to ushering in a new era of precision diagnostics and treatment for prostate cancer.

Professor, PhD Supervisor, Chief Physician
Deputy Director, Institute of Urology, Peking University
Deputy Director, Tumor Translational Center, Peking University First Hospital
Director, Scientific Research, Peking University First Hospital
National High-Level Talent Special Support Program (Ten-Thousand Talents Program)
Leading Talent in Science and Technology Innovation, Ministry of Science and Technology
Outstanding Talent of the New Century, Ministry of Education
Member, Tumor Group, Chinese Urological Association (CUA)
Deputy Leader, Translational Medicine Group, Chinese Urological Association (CUA)
Member, First Committee on Rare Diseases, Chinese Medical Association
Vice Chairman, Urology Branch, China Medical Promotion Association
Head, Genetics and Rare Diseases Collaborative Group, Chinese Urological Association
Member, Urological Oncology Committee, Chinese Medical Doctor Association
Standing Member, Hereditary Tumor Committee, Chinese Anti-Cancer Association
Executive Council Member, Rare Disease Branch, Chinese Research Hospital Association
Standing Member, Oncology Committee, Beijing Medical Association
Standing Member, Rare Disease Committee, Beijing Medical Association
Advisory Member, International VHL Alliance

Professor Gong has been dedicated to the diagnosis, prevention, and treatment of rare and complex urological tumors. He has led over 20 major national projects, including key initiatives from the Ministry of Science and Technology and the National Natural Science Foundation. His research has been published in top-tier journals such as Cancer Discovery, PNAS, and Cancer Research, with over 100 SCI-indexed papers. He holds three granted patents, one of which has successfully been commercialized.

Associate Chief Physician, Department of Urology, Peking University First Hospital PhD in Imaging and Nuclear Medicine, Peking University Health Science Center

Research Interests:

Targeted prostate biopsy
Imaging diagnostics of prostate cancer
Ultrasonography and interventional procedures for the genitourinary system

Prof. Liu has led and participated in three provincial, ministerial, and university-level research projects. In the past five years, he has published over ten SCI papers in journals such as BMC Medicine, Insights into Imaging, and Journal of Magnetic Resonance Imaging as first or corresponding author.

PhD candidate, Department of Urology, Peking University First Hospital Supervised by Prof. Kan Gong

Dr. Deng is the principal investigator of a “Qiyan” Project funded by the Beijing Natural Science Foundation. He has published 13 academic papers, including 9 SCI articles as first or co-first author. He delivered oral presentations at the 2024 and 2025 EAU (European Association of Urology) Annual Meetings, where he was awarded the Best Abstract by a Resident-in-Urology Award at EAU25. He has received numerous honors, including the National Scholarship, “Outstanding Student” of Beijing, and the “Model Student” award from Peking University.

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