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NCT Number: NCT06737588

The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI 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).

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Changming Wang

CONTACT

[email protected]

15840256553

Jun Xiao

CONTACT

[email protected]

13956934087

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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