RecruitingNot ApplicableNCT06402552

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

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

Sponsor

Chang Gung Memorial Hospital

Enrollment

370 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Magnetic Resonance Imaging Randomized Controlled Trial

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.

Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of prostate MRI scans — a shorter, simpler scan (Bp-MRI) versus the current standard longer scan (Mp-MRI) — to see which is better at detecting clinically significant prostate cancer before biopsy. **You may be eligible if...** - You are a man aged 50 or older - Your PSA blood level is between 4 and 20 ng/mL and your doctor suspects prostate cancer - You are scheduled for a prostate biopsy - Physical exam suggests the cancer, if present, is confined to the prostate - You can undergo an MRI scan **You may NOT be eligible if...** - You have had a prostate biopsy in the past 6 months - You have already been diagnosed with prostate cancer - You cannot safely have a biopsy (e.g., active urinary infection, severe bleeding disorder, blood thinners that cannot be stopped) - You cannot safely have an MRI (e.g., contrast dye allergy, claustrophobia, metal implants in the abdomen) - You have previously received any hormone therapy, chemotherapy, radiation, or immunotherapy for prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTbp-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_TESTmp-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 City, Taiwan

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NCT06402552

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