An observational study in Prostate Cancer (Diagnosis) and Clinically Significant Prostate Cancer, sponsored by Guangxi Medical University. Recruiting at 1 site in China. Open to male participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Guangxi Medical University · Observational
This is a multicenter observational study. A deep learning model integrated with multimodal imaging and digital pathology spatial registration is built based on preoperative multiparametric magnetic resonance imaging, transrectal ultrasound and postoperative digital pathological whole slide images. The study is designed to achieve accurate prediction of clinically significant prostate cancer and non-invasive risk stratification. Unnecessary prostate biopsy and overdiagnosis can be reduced to support the optimization of clinical diagnosis and treatment strategies.
This prospective and retrospective multicenter observational study enrolls patients with suspected prostate cancer who receive standardized preoperative multiparametric magnetic resonance imaging, transrectal ultrasound examination, followed by prostate biopsy or radical prostatectomy. Complete clinical data including age, BMI, prostate specific antigen indicators, PI-RADS v2.1 scores, Gleason score and ISUP grading are collected from all eligible participants.
Biomechanically constrained non-rigid spatial registration technique is applied to achieve precise alignment between preoperative multimodal images and postoperative digital pathological whole slide images using high-quality multicenter datasets. A transformer-based multimodal deep learning fusion model is developed to analyze correlations between macroscopic imaging features and microscopic pathological heterogeneity, thereby establishing an interpretable artificial intelligence framework for clinically significant prostate cancer prediction.
Comprehensive model validation is conducted via internal cross-validation, external multicenter independent verification and international public datasets. Decision curve analysis and clinical impact curve are applied to assess clinical applicability. The model serves as an intelligent auxiliary tool to refine biopsy strategies, avoid redundant puncture and excessive treatment, and facilitate early precise diagnosis and risk stratification of prostate cancer.
This is a prospective and retrospective multicenter cohort study. The study population consists of consecutive male subjects aged 40-90 years who are scheduled to undergo or have undergone prostate biopsy or radical prostatectomy, with complete standard-of-care preoperative multiparametric MRI (mpMRI), transrectal ultrasound (TRUS) images, and corresponding pathological diagnosis results. The collected data include:
Exclusion Criteria:
This is an observational study. No new treatment, drug, device, or procedure is being administered to participants. Only standard-of-care clinical data, imaging, and pathology records are collected and analyzed.
Area Under the Receiver Operating Characteristic Curve (AUC) for predicting clinically significant prostate cancer (csPCa)
The diagnostic performance of the multimodal deep learning model in predicting clinically significant prostate cancer using preoperative imaging data from this prospective and retrospective multicenter cohort. The AUC will be calculated to evaluate the model's discriminative ability.
Time frame: Baseline (at the time of imaging/pathology data collection)
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Plan to share: No — This study does not have a plan to share individual participant data due to institutional and ethical restrictions.
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Guangxi Medical University