Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis

A Prospective, Multicenter, Open-Label, Randomized, Parallel-Group, Noninferiority Trial of MRI/Ultrasound Cognitive Fusion Targeted Biopsy Combined With Ipsilateral Versus Bilateral Systematic Biopsy for Prostate Cancer Diagnosis

Prostate biopsy usually combines magnetic resonance imaging/ultrasound (MRI/US) cognitive fusion targeted biopsy with systematic biopsy. Standard bilateral systematic biopsy requires sampling from both sides of the prostate and may increase the number of biopsy cores, procedural discomfort, procedure time, pathological workload, and biopsy-related complications.

This prospective, multicenter, open-label, randomized noninferiority trial will enroll 454 biopsy-naive men with suspected prostate cancer, a unilateral prostate MRI lesion with a highest PI-RADS score of 4 or 5, and prostate-specific antigen levels of 20 ng/mL or lower. Participants will be randomly assigned in a 1:1 ratio to receive transperineal MRI/US cognitive fusion targeted biopsy combined with either a 6-core ipsilateral systematic biopsy or a standard 12-core bilateral systematic biopsy.

The primary objective is to determine whether the ipsilateral systematic biopsy strategy is noninferior to the bilateral systematic biopsy strategy for detecting clinically significant prostate cancer, defined as International Society of Urological Pathology Grade Group 2 or higher. The study will also compare overall prostate cancer detection, biopsy core numbers, pain and discomfort, procedure time, pathological workload and costs, urinary symptoms, quality of life, and biopsy-related adverse events and complications through 30 days after biopsy.

Inclusion Criteria:

• Male participants older than 18 years.
• Suspected prostate cancer and scheduled to undergo transperineal prostate biopsy.
• Prostate MRI showing a unilateral lesion with a highest Prostate Imaging Reporting and Data System (PI-RADS) score of 4 or 5.
• Serum prostate-specific antigen (PSA) level of 20 ng/mL or lower.
• Able to tolerate and undergo transperineal prostate biopsy.
• Willing to participate in the study and able to provide written informed consent.

Exclusion Criteria:

• Prior prostate biopsy.
• Prior prostate-related treatment or procedure that may affect pathological assessment or interpretation of the biopsy results, including but not limited to androgen deprivation therapy for prostate cancer, radiotherapy, focal therapy, or transurethral prostate surgery.
• Prostate MRI showing a lesion crossing the prostatic midline such that the lesion side cannot be clearly determined, or an independent contralateral lesion with a PI-RADS score of 3 or higher.
• Acute urinary tract infection, severe coagulation disorder, or any other contraindication to transperineal prostate biopsy.
• In the investigator's judgment, inability to understand the study, comply with study procedures, or provide written informed consent.