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Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy

NCT06402552 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2024-05-10

No results posted yet for this study

Summary

3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial.

3.2 Study endpoints: 3.2.1 Primary endpoint: The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core.

3.2.2 Secondary endpoints:

1. The proportion of men with a diagnosis of any PCa
2. The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa)
3. The proportion of men with a diagnosis of csPCa
4. Only in targeted biopsy
5. Only in systematic biopsy
6. The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.

Conditions

Interventions

DIAGNOSTIC_TEST

bp-MRI prostate

Biparametric MRI is considered less comprehensive compared to multiparametric MRI (mp-MRI), which includes additional parameters like dynamic contrast-enhanced MRI (DCE-MRI). However, bp-MRI offers a simpler, faster, and often less expensive alternative that still provides critical diagnostic information, particularly in the detection of clinically significant prostate cancer. It's commonly used where less comprehensive assessment is sufficient or in situations where contrast use is contraindicated.

DIAGNOSTIC_TEST

mp-MRI prostate

Multiparametric MRI is highly valued for its ability to improve the detection and characterization of clinically significant prostate cancer, aid in biopsy guidance, and help in treatment planning and monitoring. Its comprehensive approach provides crucial insights that are not as readily available through simpler imaging modalities like biparametric MRI (bp-MRI).

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-04-30
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402552 on ClinicalTrials.gov