A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy
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.
• Men ≥50 years of age
• Clinical suspicion of prostate cancer and indicated for prostate biopsy
• Serum Prostate-specific antigen (PSA) between 4\
⁃ 20 ng/mL
• Eligible for MRI study
• Digital rectal examination ≤ cT2 (organ-confined cancer)
• Able to provide written informed consent.