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Search / Trial NCT06737588

The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI in the Diagnosis of Prostate Cancer

Launched by ANHUI PROVINCIAL HOSPITAL · Dec 12, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Prostate Cancer Prostate Biospy Biparametric Magnetic Resonance Apparent Diffussion Coefficient Prostate Imaging Reporting And Data System Diagnosis

ClinConnect Summary

This clinical trial is studying how useful certain imaging measurements, called Apparent Diffusion Coefficients (ADC), are in diagnosing prostate cancer in men. The researchers want to find out if these measurements can help improve the detection of significant prostate cancer, which is classified as having a Gleason score of 3+4 or higher. They are specifically looking at men who have already had an MRI scan with a score of 3 or higher, indicating a higher chance of cancer.

To be eligible for the trial, participants must be men aged 65 to 74 who have reasons for needing a prostate biopsy, have a specific level of a blood test called PSA, and have undergone a clear and readable MRI scan. Those who have had previous prostate surgeries, other cancers, or certain health issues that prevent MRI or biopsy are not eligible. If you join the trial, you will undergo additional assessments to help determine the effectiveness of these imaging techniques in diagnosing prostate cancer. Your participation will contribute to improving cancer detection methods for other patients in the future.

Gender

MALE

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.

About Anhui Provincial Hospital

Anhui Provincial Hospital is a leading medical institution in China, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its extensive expertise in various medical fields to enhance patient outcomes and contribute to the global body of medical knowledge. With a focus on translating research findings into practical applications, Anhui Provincial Hospital is dedicated to fostering collaboration among healthcare professionals and researchers, ensuring that cutting-edge treatments and interventions are accessible to the communities it serves.

Locations

Wuhu, Anhui, China

Hefei, Anhui, China

Patients applied

0 patients applied

Trial Officials

Jun Xiao

Principal Investigator

The First Affiliated Hospital of USTC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported