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

February 10, 2025 updated by: XiaoJun, Anhui Provincial Hospital

The Addictive Diagnostic Value of Apparent Diffusion Coefficients to PI-RADS 3-5 of Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer

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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study is conducted with suspected prostate cancer. Patients with PI-RADS scores of 3-5 after completing prostate bpMRI chose to undergo prostate biopsy. Before patients undergo prostate biopsy, researchers will collecte information on age, BMI, tPSA, f/PSA, PV, PSAD, ADCmean, ADCmin, ADCmax, ADCnormal, maximum lesion diameter, location of major lesions, and so on. For prostate biopsy, systematic prostate biopsy ± bpMRI cognitive fusion targeted prostate biopsy will be completed under the conditions permitted by physical condition, and Gleason score will be clearly given by pathologists if the final diagnosis is prostate cancer. In this study, the pathological result is regarded as the gold standard. ROC curve, area under curve, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and other indicators of diagnostic test were calculated. Relevant conclusions are finally drawn by comparing the diagnostic capacity of different ADC values for prostate cancer. Meanwhile, binary logistic regression analysis will also conduct the Odds ratios (ORs) and 95% confidence intervals (CIs) will be recorded.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Department of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
        • Contact:
        • Contact:
      • Wuhu, Anhui, China, 241000
        • Not yet recruiting
        • Department of Urology, The First Affiliated Hospital of Wannan Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study is observational and does not require any intervention for patients, who only need to complete the routine diagnosis and treatment procedures. This study mainly screened patients who need to complete mainly included serum PSA test, digital rectal examination, and 3.0TbpMRI containing ADC maps and with indications of prostate biopsy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for clinically significant prostate cancer (csPCa) (Gleason score ≥ 3+4, ISUP grade ≥ 2) in patients with PI-RADS 3-5.
Time Frame: through study completion, an average of 1 month
csPCa means Gleason score ≥ 3+4， ISUP grade ≥ 2. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value. The odds ratios (ORs) and 95% confidence intervals in logistic analysis.
through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for any-grade prostate cancer (PCa) (Gleason score ≥ 3+3, ISUP grade ≥ 1) in patients with PI-RADS 3-5.
Time Frame: through study completion, an average of 1 month
agPCa means Gleason score ≥ 3+3， ISUP grade ≥ 1. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value. The odds ratios (ORs) and 95% confidence intervals in logistic analysis.
through study completion, an average of 1 month
Evaluate the diagnostic capacity of different PI-RADS scores combined with different ADC cut off values for csPCa
Time Frame: through study completion, an average of 1 month
ROC curves and AUC value (95%CI), Sensetivity, Specificity, Positive predictive value and negative predictive value.
through study completion, an average of 1 month
Compare the diagnostic value of different ADC values for csPCa in patients with 3-5 points of PI-RADS.
Time Frame: through study completion, an average of 1 month
ROC curves and AUC value (95%CI), Sensetivity, Specificity, Positive predictive value and negative predictive value.
through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Investigators

  • Principal Investigator: Jun Xiao, The First Affiliated hospital of USTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-ky-495 (bpMRI-ADC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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