Related Experiment Video
Updated: Jan 1, 2026
A Cognitive Fusion-guided Prostate Biopsy Using Multiparametric Magnetic Resonance Imaging and Transrectal Ultrasound
Published on: March 21, 2025
The Value of Prostate-specific Antigen Density for Prostate Imaging-Reporting and Data System 3 Lesions on
Magdalena Görtz1, Jan Philipp Radtke2, Gencay Hatiboglu1
1Department of Urology, University Hospital Heidelberg, Heidelberg, Germany.
Background:
Multiparametric magnetic resonance imaging (mpMRI) has excellent sensitivity in detecting significant prostate cancer (sPC). Nevertheless, uncertainty exists regarding the management of Prostate Imaging-Reporting and Data System (PI-RADS) 3 lesions.
Objective:
To investigate whether PI-RADS 3 lesions in combination with clinical parameters, especially prostate-specific antigen density (PSAD), can be used to exclude sPC.
Design, Setting, And Participants:
A total of 455 consecutive biopsy-naïve men underwent MRI-guided transperineal prostate fusion biopsy at our department between 2017 and 2018. We identified 101 patients who had exclusively one or more PI-RADS 3 lesions on mpMRI. sPC was defined as intermediate- and high-risk PC (according to the D'Amico risk classification).
Outcome Measures And Statistical Analysis:
Univariate logistic regression analysis was performed to test different clinical factors as predictors of sPC in men with PI-RADS 3 lesions. The probability of sPC prediction was calculated for different PSAD thresholds.
Results And Limitations:
Among patients with PI-RADS 3 lesions, PSAD was a significant predictor of sPC (p = 0.005). For a PI-RADS score of 3 the probability of excluding sPC was 85% (86/101), which increased to 98% (42/43) when combined with PSAD <0.1 ng/ml/ml.
Conclusions:
Inclusion of PSAD < 0.1 ng/ml/ml in the strategy for biopsy-naïve patients with equivocal mpMRI findings would allow a reduction in prostate biopsies in 43% (43/101) of cases at the cost of missing a very small number (2%, 1/43) of intermediate-risk PCs.
Patient Summary:
At high-volume tertiary care centers with significant experience in prostate multiparametric magnetic resonance imaging, immediate biopsies could be safely omitted for men with lesions with a Prostate Imaging-Reporting and Data System score of 3 and prostate-specific antigen density of PSAD < 0.1 ng/ml/ml. Any decision to omit an immediate biopsy should be associated with close monitoring.
Insights
Multiparametric MRI (mpMRI) can detect prostate cancer, but PI-RADS 3 lesions require further assessment. Combining PI-RADS 3 scores with prostate-specific antigen density (PSAD) < 0.1 ng/ml/ml can safely exclude significant prostate cancer in biopsy-naïve men.
Area of Science:
- Urology
- Radiology
- Oncology
Background:
- Multiparametric magnetic resonance imaging (mpMRI) demonstrates high sensitivity for detecting significant prostate cancer (sPC).
- Management decisions for Prostate Imaging-Reporting and Data System (PI-RADS) 3 lesions remain uncertain.
- PI-RADS 3 lesions represent an area of ambiguity in prostate cancer diagnosis using mpMRI.
Purpose of the Study:
- To determine if PI-RADS 3 lesions, when analyzed with clinical factors like prostate-specific antigen density (PSAD), can reliably exclude sPC.
- To establish a threshold for PSAD that, in conjunction with PI-RADS 3 findings, aids in the decision-making process for prostate biopsies.
- To reduce unnecessary prostate biopsies in men with equivocal mpMRI findings.
Main Methods:
- Retrospective analysis of 455 biopsy-naïve men undergoing MRI-guided transperineal prostate fusion biopsy.
- Identification of 101 patients with exclusively PI-RADS 3 lesions on mpMRI.
- Univariate logistic regression analysis to assess clinical factors, particularly PSAD, as predictors of sPC (intermediate- and high-risk).
Main Results:
- PSAD was a significant predictor of sPC in men with PI-RADS 3 lesions (p=0.005).
- The probability of excluding sPC for PI-RADS 3 lesions alone was 85%.
- Combining PI-RADS 3 with PSAD < 0.1 ng/ml/ml increased the exclusion probability to 98%.
Conclusions:
- The combination of PI-RADS 3 and PSAD < 0.1 ng/ml/ml can safely omit immediate biopsies in 43% of biopsy-naïve men.
- This strategy reduces prostate biopsies while missing only a small percentage (2%) of intermediate-risk prostate cancers.
- Close monitoring is recommended for men with PI-RADS 3 lesions and low PSAD who forgo immediate biopsy.
