RecruitingNCT07614256

A Multicenter Study of a Deep Learning Model Based on Spatial Registration of Multimodal Imaging and Digital Pathology for Predicting Clinically Significant Prostate Cancer

Sponsor: Guangxi Medical University

Trial Details

ConditionProstate Cancer (Diagnosis), Clinically Significant Prostate Cancer
InterventionNo Intervention: Observational Cohort
StatusRecruiting
Participants3,000
Est. Completion30 June 2030
Last Updated29 May 2026

Primary Outcome

Area Under the Receiver Operating Characteristic Curve (AUC) for predicting clinically significant prostate cancer (csPCa)

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Subjects who are scheduled to undergo or have undergone prostate biopsy or radical prostatectomy. 2. Subjects who have completed standard-of-care preoperative multiparametric MRI (mpMRI) and transrectal ultrasound (TRUS) examinations. 3. Subjects with complete pathological diagnosis results available. 4. Age between 40 and 90 years. 5. Able and willing to provide written informed consent (for prospective cohort participants only). Exclusion Criteria: 1. Prior history of pelvic radiation therapy or radical prostatectomy. 2. Incomplete or poor-quality mpMRI or TRUS images (e.g., motion artifacts, insufficient sequences). 3. Concurrent other primary malignant tumors. 4. Severe systemic diseases that may affect the evaluation of the prostate. 5. Subjects with incomplete clinical or pathological data. 6. Contraindications to MRI examination (e.g., incompatible metallic implants, severe claustrophobia).

Trial Sites

Countries

China
View Registry Entry

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