RecruitingNCT06737588
The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI in the Diagnosis of Prostate Cancer
The Addictive Diagnostic Value of Apparent Diffusion Coefficients to PI-RADS 3-5 of Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer
Sponsor
Anhui Provincial Hospital
Enrollment
600 participants
Start Date
Dec 1, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
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).
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria5
- 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.
Exclusion Criteria6
- 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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06737588
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