Evaluating the diagnostic value of MRI in prostate cancer detection
The Addictive Diagnostic Value of Apparent Diffusion Coefficients to PI-RADS 3-5 of Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer
This study is testing if certain MRI measurements can help doctors better detect prostate cancer in patients who are suspected of having it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Anhui Provincial Hospital Government |
| Locations | 2 sites (Hefei, Anhui and 1 other locations) |
| Trial ID | NCT06737588 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with suspected prostate cancer who have a PI-RADS score of 3-5 and meet specific biopsy indications.
Not a fit: Patients with contraindications for MRI or those with lower PI-RADS scores (1-2) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnosis, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using MRI and ADC values for prostate cancer diagnosis, suggesting this approach has potential based on prior findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hefei, Anhui and 1 other locations
- 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 USTC
- Study coordinator: Changming Wang
- Email: wcmurologist@mail.ustc.edu.cn
- Phone: 15840256553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.