NCT06737588Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06737588
What you commit to
- Study type: Observational
- Planned participants: 600
- From 1 Dec 2024 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate-related surgery;
Other
- 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;
- The patient refused to sign the informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Department of Urology, The First Affiliated Hospital of Wannan Medical College Coordinator of this site? Confirm its status | Wuhu | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.