Prostate biopsy remains the gold standard for diagnosing prostate cancer, but it carries risks such as infection, bleeding, and urinary obstruction. As a result, growing research interest has focused on developing “non-biopsy” diagnostic strategies. At the 2025 Annual Meeting of the European Association of Urology (EAU25), a study led by Professor Shouzhen Chen and Professor Benkang Shi from Qilu Hospital of Shandong University was selected for oral presentation. The study demonstrated that combining PSMA PET/CT, multiparametric MRI (PI-RADS score), and blood biomarkers—PHI and PSAD—can reduce the prostate cancer missed diagnosis rate to zero.UroStream: Congratulations on having your non-biopsy prostate cancer study selected as an oral presentation at EAU25. Could you first walk us through the key diagnostic tools used in your study—PSMA PET/CT, mpMRI (PI-RADS score), and serum markers PHI and PSAD—and how they differ from traditional imaging, PSA testing, or digital rectal examination (DRE)? What were the key findings of your non-biopsy approach?
Professor Shouzhen Chen: In our study, the primary imaging tools used were multiparametric MRI (assessed using PI-RADS scoring) and PSMA PET/CT. PSMA PET/CT, as an emerging molecular imaging modality, has seen growing clinical use in recent years and may offer higher sensitivity and specificity than conventional imaging methods. On the serum marker front, we incorporated the Prostate Health Index (PHI) and prostate-specific antigen density (PSAD). Both PHI and PSAD provide better diagnostic performance than PSA testing alone.
By integrating PSMA PET/CT, mpMRI, PHI, and PSAD, we aimed to identify men who could safely avoid biopsy. Our study included more than 200 men who initially had abnormal screening results. Using this four-parameter approach, we were able to reduce the missed diagnosis rate of prostate cancer to zero. If we relied on MRI-related markers alone, the misdiagnosis rate in our cohort was 6.9%. Adding PSAD and PSMA PET/CT brought the rate down to 2.9%. When PHI was also incorporated, both false negatives and false positives dropped to zero.
Of course, our study has its limitations. Currently, the data come from a single center, and we have only collected these four indicators. There is a lack of external validation from other institutions. We hope to conduct large-scale, multi-center studies in the near future to further confirm our findings.
02 UroStream: Is there a follow-up study planned for this research? Specifically, after implementing a “non-biopsy” strategy, how do you envision patient follow-up and monitoring?
Professor Shouzhen Chen: Many research teams both in China and abroad are actively exploring non-biopsy approaches. Our data show that the more indicators included in the analysis, the greater the diagnostic accuracy, with reduced rates of both false positives and false negatives. However, even when our model suggests a patient is unlikely to have prostate cancer, it doesn’t mean we can completely let our guard down. Regular follow-up is still essential. In clinical practice, we’ve encountered prostate cancer patients whose PSMA PET/CT and mpMRI results appeared atypical, raising concerns about potential missed diagnoses.
As mentioned earlier, our current dataset includes only four indicators from a single center, and external validation is necessary. We have already tested a three-indicator model (mpMRI, PSAD, and multiparametric MRI) in other centers, and the results were consistent with our own. However, after incorporating the fourth indicator—PHI—we need to expand the sample size through multi-center studies to validate the accuracy of this four-marker model.
03 UroStream: Your study demonstrates the effectiveness of combining PET/CT, mpMRI, and serum biomarkers for early diagnosis and screening. Do you see this combination being useful in other clinical scenarios, such as post-surgical monitoring of minimal residual disease or assessing treatment response?
Professor Shouzhen Chen: I believe one of the most important applications of this diagnostic model is in confirming prostate cancer among patients with abnormal PSA results during initial screening. However, looking ahead, as focal therapy becomes more common for prostate cancer, long-term monitoring for these patients will become increasingly important. These diagnostic models could play a significant role in the follow-up of patients receiving focal therapies.
In addition, as screening and biopsies become more frequent, we often encounter patients whose initial biopsy is negative. Whether or not these patients should undergo repeat biopsies—second or even third attempts—is a key question. A reliable prediction model could help reduce unnecessary repeat procedures. When certain indicators begin to change, or when prostate cancer characteristics become more pronounced, we can better identify at-risk patients and provide more precise diagnostic and therapeutic recommendations.
04 UroStream: “Non-biopsy” diagnosis and targeted fusion biopsies have become key discussion points in recent years. In your view, how will prostate cancer screening and diagnosis evolve toward more individualized and precise approaches?
Professor Shouzhen Chen: That’s an important and broad topic. Traditionally, prostate cancer screening has primarily relied on PSA testing for the initial assessment. If a patient’s PSA level is abnormal, we typically recommend further evaluation with MRI and, if necessary, a biopsy. However, many patients with elevated PSA do not actually have prostate cancer, and some choose to forgo MRI or biopsy due to concerns about cost, invasiveness, or anxiety around the procedures—especially biopsies, which are invasive and can be intimidating.
Looking ahead, we can enhance PSA screening by incorporating the Prostate Health Index (PHI) as a complementary marker. PHI is relatively low-cost and can help us better identify patients at higher risk of prostate cancer. Additionally, certain MRI scans can now be completed quickly and at a lower cost, with less stringent equipment requirements making them a feasible tool for broader screening purposes. By integrating multiple markers such as multiparametric MRI, PHI, and PSA—we can more accurately detect patients at risk of clinically significant prostate cancer.
Even for patients who ultimately need a biopsy, improved communication and better risk stratification can help increase their acceptance of the procedure, ultimately improving biopsy positivity rates and avoiding unnecessary interventions.
I believe the future of precision in prostate cancer screening will follow two major paths: first, improving the precision of biopsy by basing it on more accurate screening data; and second, for patients at extremely high risk, using advanced tools like PSMA PET/CT to potentially achieve a reliable diagnosis without the need for biopsy.
Professor Shouzhen Chen
Associate Chief Physician, Associate Professor, and Master’s Supervisor at Qilu Hospital of Shandong University Taishan Scholar Young Expert National Talent Development Scholar at Qilu Hospital, Shandong University Drafting Committee Member, CSCO Guidelines for Prostate Cancer Diagnosis and Treatment Chair of the Youth Committee, Multidisciplinary Joint Committee on Urological and Male Reproductive Tumors, Shandong Medical Association Vice Chair of the Youth Committee, Urological and Male Reproductive Tumors Branch, Shandong Anti-Cancer Association Committee Member, Urology Branch, Shandong Medical Association
Professor Chen has published over 20 SCI-indexed articles as first or corresponding author in journals such as PNAS, Cancer Research, and PCPD. He has led several projects funded by the National Natural Science Foundation of China and the Shandong Provincial Key R&D Program, and has received the First Prize of the Shandong Science and Technology Progress Award.
