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

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06737588
• Lead Sponsor: Anhui Provincial Hospital

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).

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 Timeline

• Study Start: 2024-12-01
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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.	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.
Evaluate the diagnostic capacity of different PI-RADS scores combined with different ADC cut off values for csPCa	through study completion, an average of 1 month	ROC curves and AUC value (95%CI), Sensetivity, Specificity, Positive predictive value and negative predictive value.
Compare the diagnostic value of different ADC values for csPCa in patients with 3-5 points of PI-RADS.	through study completion, an average of 1 month	ROC curves and AUC value (95%CI), Sensetivity, Specificity, Positive predictive value and negative predictive value.

Trial Locations

Locations (2)

Department of Urology, The First Affiliated Hospital of Wannan Medical College; 🇨🇳 Wuhu, Anhui, China

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