RecruitingNot Applicable

Multimodal Imaging and Digital Pathology for Prostate Cancer Prediction

China3,000 participantsStarted 2025-05-30

Plain-language summary

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.

Who can participate

Age range

40 Years – 90 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects who are scheduled to undergo or have undergone prostate biopsy or radical prostatectomy.
. Subjects who have completed standard-of-care preoperative multiparametric MRI (mpMRI) and transrectal ultrasound (TRUS) examinations.
. Subjects with complete pathological diagnosis results available.
. Age between 40 and 90 years.
. Able and willing to provide written informed consent (for prospective cohort participants only).

Exclusion criteria

. Prior history of pelvic radiation therapy or radical prostatectomy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline (at the time of imaging/pathology data collection)

Trial details

NCT IDNCT07614256

SponsorGuangxi Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-06-30

Contact for this trial

Caigou Shi, MD

+86 13677729003 shicaigou@sr.gxmu.edu.cn

View on ClinicalTrials.gov More Prostate Cancer (Diagnosis) trials