The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI in the Diagnosis of Prostate Cancer
Recruiting · NCT06737588 · Observational (researchers observe without assigning treatment) · Lead sponsor: Anhui Provincial Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
2 locations listed.
- 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
- Department of Urology, The First Affiliated Hospital of Wannan Medical College - Wuhu, Anhui, China