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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
454
Transperineal 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.
Transperineal 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.
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGDetection 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%.
Time frame: Day 14 after biopsy
Overall Prostate Cancer Detection Rate
The proportion of participants with prostate cancer detected on any biopsy specimen, regardless of ISUP Grade Group.
Time frame: Day 14 after biopsy
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.
Time frame: Day 14 after biopsy
High-Grade Prostate Cancer Detection Rate
The proportion of participants with biopsy pathology showing ISUP Grade Group 3 or higher.
Time frame: Day 14 after biopsy
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.
Time frame: Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain
Overall Discomfort Numeric Rating Scale Score
Overall procedural discomfort related to instrument insertion, ultrasound positioning or pressure, prostatic pressure, pelvic floor traction, foreign-body sensation, positioning, and the biopsy procedure will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10. A score of 0 indicates no discomfort and a score of 10 indicates the worst imaginable discomfort. Higher scores indicate greater discomfort.
Time frame: Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort
Procedure Time
Procedure time in minutes, measured from the start of local anesthesia to completion of the final biopsy core. For the TB+iSB group, timing begins when local anesthesia is started on the MRI lesion side. For the TB+SB group, timing begins when bilateral local anesthesia is started.
Time frame: During the biopsy procedure
Total Number of Biopsy Cores
The total number of biopsy cores, including MRI-targeted and systematic biopsy cores, obtained for each participant will be recorded.
Time frame: During the biopsy procedure
Number of Pathology Specimen Containers
The total number of pathology specimen containers generated from the biopsy procedure will be recorded for each participant.
Time frame: Periprocedural
Total Pathology-Related Costs
Total pathology-related costs associated with biopsy specimen handling, processing, histological examination, and pathology reporting will be obtained from the applicable hospital records for each participant.
Time frame: Up to 2 weeks after biopsy
Incidence of Biopsy-Related Adverse Events and Complications
The proportion of participants experiencing any biopsy-related adverse event or complication will be assessed. Events include gross hematuria, hematospermia, perineal hematoma, fever or infection, urinary retention, syncope, emergency department visits, unplanned or prolonged hospitalization, serious adverse events, and additional medical interventions required because of a complication.
Time frame: From biopsy through 30 days after biopsy; assessed within 30 minutes, at 24 hours, day 7 (±2 days), and day 30 (±7 days)
Severity of Biopsy-Related Complications by Clavien-Dindo Grade
The maximum Clavien-Dindo grade of biopsy-related complications will be recorded for each participant. Grades range from I to V, with higher grades indicating greater severity: Grade I indicates a minor deviation from the expected postoperative course; Grade II requires pharmacological treatment; Grade III requires an intervention; Grade IV indicates a life-threatening complication requiring intensive care; and Grade V indicates death.
Time frame: From biopsy through 30 days after biopsy
Change From Baseline in International Prostate Symptom Score
The International Prostate Symptom Score consists of 7 questions assessing lower urinary tract symptoms. The total score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms. Change from baseline will be calculated as the score at 7 days after biopsy minus the baseline score.
Time frame: Baseline and 7 days after biopsy (±2 days)
Change From Baseline in IPSS Quality of Life Score
The quality of life question associated with the International Prostate Symptom Score ranges from 0 to 6, with higher scores indicating greater dissatisfaction with the participant's urinary condition. Change from baseline will be calculated as the score at 7 days after biopsy minus the baseline score.
Time frame: Baseline and 7 days after biopsy (±2 days)
Number of Histology Slides
The total number of histology slides generated for biopsy specimen processing and pathological diagnosis will be recorded for each participant.
Time frame: Up to 2 weeks after biopsy
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