NCT06737588 The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI in the Diagnosis of Prostate Cancer
| NCT ID | NCT06737588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Provincial Hospital |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Jun Xiao
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of USTC
Frequently Asked Questions
Who can join the NCT06737588 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06737588 currently recruiting?
Yes, NCT06737588 is actively recruiting participants. Contact the research team at wcmurologist@mail.ustc.edu.cn for enrollment information.
Where is the NCT06737588 trial being conducted?
This trial is being conducted at Hefei, China, Wuhu, China.
Who is sponsoring the NCT06737588 clinical trial?
NCT06737588 is sponsored by Anhui Provincial Hospital. The principal investigator is Jun Xiao at The First Affiliated Hospital of USTC. The trial plans to enroll 600 participants.
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