CompletedNot Applicable

The Application of Multimodal Artificial Intelligence Systems in Prostate Cancer Diagnosis and Prognosis Analysis

China1,651 participantsStarted 2024-10-10

Plain-language summary

Prostate-specific antigen (PSA) testing has limited specificity for prostate cancer diagnosis, leading to a high rate of unnecessary biopsies. This multi-center study aims to develop and validate a non-invasive, multi-modal artificial intelligence model that combines cell-free DNA (cfDNA) profiles with multi-parametric MRI (mpMRI). The primary goal is to improve the accuracy of prostate cancer detection and risk stratification, particularly for men with PSA levels in the 4-10 ng/mL "gray zone," thereby providing a robust tool to guide clinical decision-making and reduce avoidable invasive procedures.

Who can participate

Age range

18 Years – 80 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: * Men aged 18-80 years with a clinical indication for prostate or pelvic magnetic resonance (MR) examination. * Patients with normal prostate, benign prostatic hyperplasia, or prostate cancer. * First visit on January 1, 2014, or later. Exclusion Criteria: * Diagnosis of any other malignancy within the previous 5 years. * Prior transurethral resection or enucleation of the prostate before imaging. * Any condition deemed by the investigator to make the patient unsuitable for study participation.

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

Sensitivity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

Timeframe: Through completion of study and all data analysis which may take up to one year.

Specificity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

Timeframe: Through completion of study and all data analysis which may take up to one year.

ROC value of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

Timeframe: Through completion of study and all data analysis which may take up to one year.

Trial details

NCT IDNCT06589154

SponsorShanghai Changzheng Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Healthy People trials

Plain-language summary

Who can participate

Age range

18 Years – 80 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.

What they're measuring

Sensitivity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

Timeframe: Through completion of study and all data analysis which may take up to one year.

Specificity of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

Timeframe: Through completion of study and all data analysis which may take up to one year.

ROC value of Prostate Cancer Multimodal Model in Predicting Prostate Biopsy Pathology Outcomes (Benign or Malignant)

Timeframe: Through completion of study and all data analysis which may take up to one year.