Opportunistic Prostate Cancer Screening with Biparametric Magnetic Resonance Imaging (VISIONING).

BACKGROUND: This study investigates the use of biparametric magnetic resonance imaging (bpMRI) as primary opportunistic screening for prostate cancer (PCa) without using a prostate-specific antigen (PSA) cut-off. OBJECTIVE: The primary endpoint was to assess the efforts and effectiveness of identifying 20 participants with clinically significant prostate cancer (csPCa) using bpMRI. DESIGN, SETTING, AND PARTICIPANTS: Biopsy-naïve men aged over 45 yr were included. All participants underwent 3 Tesla bpMRI, PSA, and digital rectal examination (DRE). Targeted-only biopsy was performed in participants with Prostate Imaging Reporting and Data System (PI-RADS) ≥3. Men with negative bpMRI but suspicious DRE or elevated PSA/PSA density had template biopsies. Preintended protocol adjustments were made after an interim analysis for PI-RADS 3 lesions: no biopsy and follow-up MRI after 6 mo and biopsy only if lesions persisted or upgraded. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Biopsy results underwent a comparison using Fisher's exact test and univariable logistic regression to identify prognostic factors for positive biopsy. RESULTS AND LIMITATIONS: A total of 229 men were enrolled in this study, of whom 79 underwent biopsy. Among these men, 77 displayed suspicious PI-RADS lesions. PCa was detected in 29 participants (12.7%), of whom 21 had csPCa (9.2%). Biparametric MRI detected 21 csPCa cases, while PSA and DRE would have missed 38.1%. Protocol adjustment led to a 54.6% biopsy reduction in PI-RADS 3 lesions. Overall, in this cohort of men with a median PSA value of 1.26 ng/ml, 10.9 bpMRI scans were needed to identify one participant with csPCa. A major limitation of the study is the lack of a control cohort undergoing systematic biopsies. CONCLUSIONS: Opportunistic screening utilising bpMRI as a primary tool has higher sensitivity in detecting csPCa than classical screening methods. PATIENT SUMMARY: Screening with biparametric magnetic resonance imaging (bpMRI) and targeted biopsy identified clinically significant prostate cancer in every 11th man, regardless of the prostate-specific antigen (PSA) levels. Preselecting patients based on PSA >1 ng/ml and a positive family history of prostate cancer, as well as other potential blood tests may further improve the effectiveness of bpMRI in this setting.

Initial experience with AI Pathway Companion: Evaluation of dashboard-enhanced clinical decision making in prostate cancer screening.

PURPOSE: Rising complexity of patients and the consideration of heterogeneous information from various IT systems challenge the decision-making process of urological oncologists. Siemens AI Pathway Companion is a decision support tool that provides physicians with comprehensive patient information from various systems. In the present study, we examined the impact of providing organized patient information in comprehensive dashboards on information quality, effectiveness, and satisfaction of physicians in the clinical decision-making process. METHODS: Ten urologists in our department performed the entire diagnostic workup to treatment decision for 10 patients in the prostate cancer screening setting. Expenditure of time, information quality, and user satisfaction during the decision-making process with AI Pathway Companion were recorded and compared to the current workflow. RESULTS: A significant reduction in the physician's expenditure of time for the decision-making process by -59.9% (p < 0,001) was found using the software. System usage showed a high positive effect on evaluated information quality parameters completeness (Cohen's d of 2.36), format (6.15), understandability (2.64), as well as user satisfaction (4.94). CONCLUSION: The software demonstrated that comprehensive organization of information improves physician's effectiveness and satisfaction in the clinical decision-making process. Further development is needed to map more complex patient pathways, such as the follow-up treatment of prostate cancer.

Diagnostic accuracy and clinical implications of robotic assisted MRI-US fusion guided target saturation biopsy of the prostate.

MRI-targeted prostate biopsy improves detection of clinically significant prostate cancer (PCa). However, up to 70% of PCa lesions display intralesional tumor heterogeneity. Current target sampling strategies do not yet adequately account for this finding. This prospective study included 118 patients who underwent transperineal robotic assisted biopsy of the prostate. We identified a total of 58 PCa-positive PI-RADS lesions. We compared diagnostic accuracy of a target-saturation biopsy strategy to accuracy of single, two, or three randomly selected targeted biopsy cores and analysed potential clinical implications. Intralesional detection of clinically significant cancer (ISUP ≥ 2) was 78.3% for target-saturation biopsy and 39.1%, 52.2%, and 67.4% for one, two, and three targeted cores, respectively. Target-saturation biopsies led to a more accurate characterization of PCa in terms of Gleason score and reduced rates of significant cancer missed. Compared to one, two, and three targeted biopsy cores, target-saturation biopsies led to intensified staging procedures in 21.7%, 10.9, and 8.7% of patients, and ultimately to a potential change in therapy in 39.1%, 26.1%, and 10.9% of patients. This work presents the concept of robotic-assisted target saturation biopsy. This technique has the potential to improve diagnostic accuracy and thus individual staging procedures and treatment decisions.

Toward a Platform for Structured Data Acquisition in Oncology: A Pilot Study on Prostate Cancer Screening.

INTRODUCTION: Physicians spend an ever-rising amount of time to collect relevant information from highly variable medical reports and integrate them into the patient's health condition. OBJECTIVES: We compared synoptic reporting based on data elements to narrative reporting in order to evaluate its capabilities to collect and integrate clinical information. METHODS: We developed a novel system to align medical reporting to data integration requirements and tested it in prostate cancer screening. We compared expenditure of time, data quality, and user satisfaction for data acquisition, integration, and evaluation. RESULTS: In a total of 26 sessions, 2 urologists, 2 radiologists, and 2 pathologists conducted the diagnostic work-up for prostate cancer screening with both narrative reporting and the novel system. The novel system led to a significantly reduced time for collection and integration of patient information (91%, p < 0.001), reporting in radiology (44%, p < 0.001) and pathology (33%, p = 0.154). The system usage showed a high positive effect on evaluated data quality parameters completeness, format, understandability, as well as user satisfaction. CONCLUSION: This study provides evidence that synoptic reporting based on data elements is effectively reducing time for collection and integration of patient information. Further research is needed to assess the system's impact for different patient journeys.

Autonomous Detection and Classification of PI-RADS Lesions in an MRI Screening Population Incorporating Multicenter-Labeled Deep Learning and Biparametric Imaging: Proof of Concept.

BACKGROUND: Opportunistic prostate cancer (PCa) screening is a controversial topic. Magnetic resonance imaging (MRI) has proven to detect prostate cancer with a high sensitivity and specificity, leading to the idea to perform an image-guided prostate cancer (PCa) screening; Methods: We evaluated a prospectively enrolled cohort of 49 healthy men participating in a dedicated image-guided PCa screening trial employing a biparametric MRI (bpMRI) protocol consisting of T2-weighted (T2w) and diffusion weighted imaging (DWI) sequences. Datasets were analyzed both by human readers and by a fully automated artificial intelligence (AI) software using deep learning (DL). Agreement between the algorithm and the reports-serving as the ground truth-was compared on a per-case and per-lesion level using metrics of diagnostic accuracy and k statistics; Results: The DL method yielded an 87% sensitivity (33/38) and 50% specificity (5/10) with a k of 0.42. 12/28 (43%) Prostate Imaging Reporting and Data System (PI-RADS) 3, 16/22 (73%) PI-RADS 4, and 5/5 (100%) PI-RADS 5 lesions were detected compared to the ground truth. Targeted biopsy revealed PCa in six participants, all correctly diagnosed by both the human readers and AI. CONCLUSIONS: The results of our study show that in our AI-assisted, image-guided prostate cancer screening the software solution was able to identify highly suspicious lesions and has the potential to effectively guide the targeted-biopsy workflow.