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RECRUITING
NCT06402552
NA

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

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy

Key Details

Gender

MALE

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

370

Start Date

2024-05-01

Completion Date

2025-12-31

Last Updated

2024-05-10

Healthy Volunteers

No

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).

Locations (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan