Evaluating the diagnostic value of MRI in prostate cancer detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the diagnostic effectiveness of various apparent diffusion coefficient (ADC) values derived from biparametric MRI (bpMRI) in patients suspected of having prostate cancer. Participants with PI-RADS scores of 3-5 will undergo prostate biopsy after their bpMRI scans, and data on various clinical parameters will be collected. The study will analyze the diagnostic capacity of different ADC values in identifying clinically significant prostate cancer, using pathological results as the gold standard. Statistical methods, including ROC curve analysis and logistic regression, will be employed to evaluate the diagnostic performance of the ADC values.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient met at least one indication of prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) https://rs.yiigle.com/cmaid/1442948 );
2. Serum PSA test was completed in the patient with tPSA \< 100 ng/ml;
3. Primary prostate tumor lesion, no history of other tumors;
4. Completed 3.0T bpMRI examination, PI-RADS score ≥3 score, the image is clear and readable;
5. Patients fully understand the relevant contents of the study and voluntarily sign the informed consent.

Exclusion Criteria:

1. The patient has contraindications for MRI;
2. PI-RADS 1-2 of bpMRI;
3. The patient had contraindications to prostate biopsy or explicitly refused biopsy;
4. bpMRI indicated that the patient had multiple lymph nodes or bone metastases;
5. Previous prostate-related surgery;
6. The patient refused to sign the informed consent.

Where it's running

• Department of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
  Hefei, Anhui, China Recruiting
• Department of Urology, The First Affiliated Hospital of Wannan Medical College
  Wuhu, Anhui, China Not yet recruiting

Study contacts

• Principal investigator: Jun Xiao — The First Affiliated Hospital of University of Science and Technology of China
• Study coordinator: Changming Wang
• Email: wcmurologist@mail.ustc.edu.cn
• Phone: 15840256553

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.