CascadeDiagnose Prostate MRI

This multicenter clinical study is evaluating CascadeDiagnose Prostate MRI, an artificial-intelligence software tool that analyzes standard prostate MRI scans-T2-weighted, diffusion-weighted, and ADC images-to help radiologists detect suspicious prostate lesions, estimate cancer risk, and distinguish prostate cancer from benign conditions. The study will take place at six hospitals in Guangxi and plans to enroll at least 2,000 eligible men aged 18 or older who have had prostate MRI and have confirmed pathology results. It includes a retrospective phase using existing records and a prospective phase in which participants provide written informed consent. The main goals are to measure the system's diagnostic accuracy (AUC, sensitivity, and specificity), compare it with readings by radiologists, assess safety and rates of rejected or indeterminate results, and see whether it improves reading efficiency or helps reduce unnecessary biopsies. To protect patient privacy, raw MRI, medical-record, and pathology data remain inside each hospital; only de-identified, encrypted intermediate results are shared through a secure distributed network. The study requires ethics approval and trial registration before enrollment, and its results may help determine whether this AI tool is safe and effective for clinical use.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

1. Male patients aged ≥ 18 years undergoing prostate MRI examination.
2. Complete MRI sequences including at minimum T2WI, DWI, and ADC sequences.
3. Definitive pathological diagnosis (prostate biopsy or post-surgical pathology) with complete Gleason-score information.
4. Complete clinical data including serum PSA level, age, and prior medical history.
5. Patient informed consent (written informed consent required for the prospective phase).

Exclusion Criteria:

1. Substantial MRI image degradation caused by motion artifacts or metal artifacts that severely impair interpretation.
2. Prior prostate biopsy, prostate surgery, radiotherapy, or endocrine therapy.
3. Medical history of other malignant neoplasms.
4. Missing key MRI data or reference-standard materials required for primary-endpoint evaluation, precluding assessment of primary study outcomes.
5. Severe systemic diseases (e.g., heart failure, end-stage renal disease) interfering with imaging assessment or prognostic evaluation.

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