The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI in the Diagnosis of Prostate Cancer
Recruiting now
Conditions studied: Prostate Cancer
In brief
The goal of this study is to evaluate the diagnostic value of different ADC values (incuding ADCmin, ADCmean, ADCratio and ADCrange) of bpMRI in patients with PI-RADS 3-5. The main aim is to evaluate whether different ADC values improve the diagnosis of clinically significant prostate cancer (Gleasonscore≥3+4, ISUP grade ≥2) and any-grade prostate cancer (Gleasonscore≥3+3, ISUP grade ≥1).
Key facts
- Study ID
- NCT06737588
- Run by
- Anhui Provincial Hospital
- People needed
- 600
- Starts
- 2024-12-01
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2025-02-11
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- The patient met at least one indication of prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) https://rs.yiigle.com/cmaid/1442948 );
- Serum PSA test was completed in the patient with tPSA < 100 ng/ml;
- Primary prostate tumor lesion, no history of other tumors;
- Completed 3.0T bpMRI examination, PI-RADS score ≥3 score, the image is clear and readable;
- Patients fully understand the relevant contents of the study and voluntarily sign the informed consent.
You may not qualify if…
- The patient has contraindications for MRI;
- PI-RADS 1-2 of bpMRI;
- The patient had contraindications to prostate biopsy or explicitly refused biopsy;
- bpMRI indicated that the patient had multiple lymph nodes or bone metastases;
- Previous prostate-related surgery;
- The patient refused to sign the informed consent.
Where it is 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 (enrolling)
- Department of Urology, The First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China
Full record on ClinicalTrials.gov
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