NCT06737588

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Dec 2024Mar 2027

Study Start

First participant enrolled

December 1, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

December 12, 2024

Last Update Submit

February 10, 2025

Conditions

Prostate Cancer

Keywords

Prostate cancerProstate biospyBiparametric Magnetic ResonanceApparent diffussion coefficientProstate Imaging-Reporting and Data SystemDiagnosis

Outcome Measures

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.

    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 Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China

Hefei, Anhui, 230001, China

RECRUITING

Department of Urology, The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jun Xiao

    The First Affiliated Hospital of USTC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changming Wang

CONTACT

15840256553wcmurologist@mail.ustc.edu.cn

Jun Xiao

CONTACT

13956934087anhuiurology@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief Physician

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations

CN(2)