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.
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.
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.
Parallel
MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy
Procedure/SurgeryTransperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion. This will be followed by a 6-core systematic biopsy limited to the MRI lesion side, sampling the medial and lateral regions of the base, midgland, and apex. Local anesthesia will be limited to the MRI lesion side.
MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy
Procedure/SurgeryTransperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion. This will be followed by a standard 12-core bilateral systematic biopsy sampling the medial and lateral regions of the base, midgland, and apex on both sides of the prostate. Bilateral local anesthesia will be administered.
Detection Rate of Clinically Significant Prostate Cancer
The proportion of participants with clinically significant prostate cancer detected by the assigned biopsy strategy. Clinically significant prostate cancer is defined as biopsy pathology showing International Society of Urological Pathology (ISUP) Grade Group 2 or higher. The between-group risk difference will be calculated as TB+iSB minus TB+SB. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval is greater than -15%.
Overall Prostate Cancer Detection Rate
The proportion of participants with prostate cancer detected on any biopsy specimen, regardless of ISUP Grade Group.
Clinically Insignificant Prostate Cancer Detection Rate
The proportion of participants with biopsy pathology showing ISUP Grade Group 1 prostate cancer and no lesion with ISUP Grade Group 2 or higher.
High-Grade Prostate Cancer Detection Rate
The proportion of participants with biopsy pathology showing ISUP Grade Group 3 or higher.
Pain Numeric Rating Scale Score
Biopsy-related pain associated with local anesthesia, needle puncture, and biopsy core acquisition will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the worst imaginable pain. Higher scores indicate greater pain.
Real-Time Ultrasound Visibility of MRI-Suspicious Lesions
Each MRI-suspicious lesion designated as L1, L2, or L3 will be classified according to whether it can be identified on real-time ultrasound during MRI/ultrasound cognitive fusion targeted biopsy. Categories are visible, not visible, uncertain, and not applicable. The number and proportion of MRI-suspicious lesions in each category will be reported.
ISUP Grade Group Concordance Between Biopsy and Radical Prostatectomy Pathology
Among participants who undergo radical prostatectomy, the relationship between biopsy ISUP Grade Group and radical prostatectomy ISUP Grade Group will be classified into three mutually exclusive categories: concordant, upgraded, or downgraded. Concordant is defined as the same ISUP Grade Group on biopsy and radical prostatectomy pathology; upgraded is defined as a higher ISUP Grade Group on radical prostatectomy pathology than on biopsy pathology; and downgraded is defined as a lower ISUP Grade Group on radical prostatectomy pathology than on biopsy pathology. The number and proportion of participants in each category will be reported.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Huai'an First People's Hospital
Collaborator
Northern Jiangsu People's Hospital
Collaborator
Beijing Hospital
Collaborator
The First People's Hospital of Changzhou
Collaborator
Nantong First People's Hospital
Collaborator
