Two Studies of Dr. Yong Xu's Teamat the 2023 EAU Congress, Provided New Insights into Prostate Cancer Biopsies

The 38th Annual Congress of the European Association of Urology (EAU23) took place in Milan, Italy, from March 10 to 13, 2023. EAU Congress is one of the most highly anticipated urology conferences in Europe and worldwide, attracting over 15,000 urology experts from around the globe each year. At this year’s EAU Congress, Dr. Yong Xu’s team from the Second Hospital of Tianjin Medical University had two related studies on prostate cancer selected for presentation, exploring radical excision surgery without biopsies for highly suspicious prostate cancer patients and comparing regional saturation biopsies to targeted biopsies for initial evaluation of suspected prostate cancer patients. These research findings offer new perspectives on prostate cancer biopsies and non-invasive diagnostics.

Radical Excision Surgery without Biopsies for Highly Suspicious Prostate Cancer Patients: An Open-Label, Single-Arm Clinical Study

Research Introduction

Prostate cancer (PCa) is the most common malignant tumor in the field of urology, seriously affecting men’s health and life. Currently, both domestic and international guidelines recommend prostate biopsy as the gold standard for diagnosing prostate cancer. However, prostate biopsies still carry risks of postoperative bleeding, infection, urinary retention, and other complications. Moreover, the diagnostic procedure of prostate biopsy, being invasive, leads to extended hospital stays, increased pathology costs, and psychological anxiety, causing many patients to be apprehensive and reluctant to undergo the procedure. In this context, urologists face the important challenge of finding alternative methods for diagnosing PCa that can replace the current biopsy approach, thus avoiding these risks. In recent years, with the continuous development of new technologies such as multiparametric magnetic resonance imaging (mp-MRI), Prostate Imaging Reporting and Data System (PI-RADS) scoring, and PSMA PET/CT, the sensitivity and specificity of imaging for diagnosing PCa have significantly improved, greatly promoting early detection of prostate cancer.

Based on these considerations, we initiated a single-arm prospective clinical study: an open-label investigation of prostate cancer biopsies without the need for biopsies in highly suspicious (PI-RADS>3) prostate cancer patients using 68Ga-PSMA PET/CT

Between December 2017 and December 2022, 59 suspicious prostate cancer patients (SUVmax≥4 on PSMA PET/CT or PI-RADS≥4 on mpMRI) were enrolled in this study. Radical excision surgery of the prostate without biopsies was successfully performed on these patients. Pathological results confirmed prostate cancer in 58 cases (98.3%), with 52 cases (88.1%) being clinically significant cancers and 1 case diagnosed as high-grade prostatic intraepithelial neoplasia (HGPIN). Subsequent analysis of the 52 samples revealed a median SUVmax of 14.0 (IQR: 9.9-22.8) for cancer lesions and 6.6 for HGPIN lesions. Subgroup analysis showed median SUVmax values of 5.85 for ISUP grade 1, 15.4 for ISUP grade 2, 17.0 for ISUP grade 3, 13.6 for ISUP grade 4, and 14.4 for ISUP grade 5.

Furthermore, we found that patients with clinically significant prostate cancer had higher prostate-specific antigen density (PSAD) median values (0.67 vs. 0.23 ng/ml^2, P<0.001) and lower prostate volume (PV) median values (31.5 vs. 65.0 ml, P<0.001) compared to patients with clinically non-significant prostate cancer and those with HGPIN. Importantly, we developed a Prostate Biopsy-Free Score System (PBFSS) based on PSA levels, PV, PSAD, PI-RADS score, and PSMA-PET/CT SUVmax. We found that patients with a PBFSS score greater than 2 should undergo radical prostatectomy without biopsies.

Comparison of Regional Saturation Biopsy with Targeted Biopsy as an Assessment for Initial Evaluation of Suspected Prostate Cancer Patients (PI-RADS≥3): A Prospective Randomized Controlled Clinical Study

Currently, early diagnosis of prostate cancer remains a major scientific challenge in the field of urology. Due to the significant advantages demonstrated by multiparametric magnetic resonance imaging (mpMRI) in the early diagnosis of prostate cancer, some experts have combined mpMRI with ultrasound imaging to design “targeted biopsies (TB)” and gradually promoted their use in some large urology centers both domestically and internationally. However, due to the high technical and equipment requirements for targeted biopsies and the lack of clear operating standards, the positive biopsy rates vary widely among different surgeons. Therefore, international guidelines still recommend combining targeted biopsies with a 12-core systematic biopsy (SB) as the recommended biopsy strategy for initial evaluation of suspected prostate cancer patients. Recent research evidence suggests that most suspicious prostate cancer patients benefit from targeted biopsies of the main lesion (Region Of Interest, ROI) and perilesional sampling, while supplemental systematic biopsies (SB) increase unnecessary biopsy cores, potential harm, and patient burden, identifying clinically insignificant prostate cancers.

Based on the advantages of targeted and systematic biopsies, our team proposed a new biopsy diagnostic concept, the “Regional Saturation Biopsy (RSB)” model. This model is primarily based on precise preoperative localization and planning of suspicious areas in the prostate (ROI and the surrounding 1cm area) using mpMRI imaging. Subsequently, only the suspicious area is subjected to ultrasound-guided saturation biopsy (9 cores) to enhance biopsy accuracy, reduce biopsy-related complications, decrease anesthesia time, and improve patient satisfaction. Based on this concept, we designed and produced relevant biopsy templates and support structures, successfully conducting a prospective randomized controlled clinical trial of “Regional Saturation Biopsy and Fusion Targeted Biopsy for Suspicious Prostate Cancer Patients with PI-RADS≥3” (Chinese Clinical Trial Registry number: ChiCTR2100053963). The research results revealed that regional saturation biopsy significantly outperformed targeted biopsy in detecting overall prostate cancer and clinically significant prostate cancer, especially for PI-RADS 3, ROI≤0.5cm^2, and pathological nerve invasion.