Prostate Cancer
Conditions
Keywords
Prostate Biopsy, MRI-Targeted Biopsy, Cognitive Fusion Biopsy, Transperineal Prostate Biopsy, Systematic Biopsy, Ipsilateral Systematic Biopsy, Bilateral Systematic Biopsy, Clinically Significant Prostate Cancer, PI-RADS, Noninferiority Trial
Brief summary
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.
Interventions
PROCEDUREMRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy
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.
PROCEDUREMRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy
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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Huai'an First People's Hospital
Northern Jiangsu People's Hospital
Beijing Hospital
The First People's Hospital of Changzhou
Nantong First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and biopsy operators are not masked because the two groups differ in the systematic biopsy template, number of biopsy cores, sampling extent, and extent of local anesthesia. Pathologists and core outcome assessors will remain unaware of study-group allocation whenever feasible. Statistical analyses will be performed using coded group labels whenever feasible.
Intervention model description
Participants will be stratified by the highest PI-RADS score (PI-RADS 4 or PI-RADS 5) and randomly assigned in a 1:1 ratio to one of two parallel biopsy strategy groups: MRI/ultrasound cognitive fusion targeted biopsy plus ipsilateral 6-core systematic biopsy, or MRI/ultrasound cognitive fusion targeted biopsy plus standard bilateral 12-core systematic biopsy.
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Clinically Significant Prostate Cancer | Day 14 after biopsy | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Prostate Cancer Detection Rate | Day 14 after biopsy | The proportion of participants with prostate cancer detected on any biopsy specimen, regardless of ISUP Grade Group. |
| Clinically Insignificant Prostate Cancer Detection Rate | Day 14 after biopsy | 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 | Day 14 after biopsy | The proportion of participants with biopsy pathology showing ISUP Grade Group 3 or higher. |
| Pain Numeric Rating Scale Score | Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain | 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. |
| Overall Discomfort Numeric Rating Scale Score | Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort | 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. |
| Procedure Time | During the biopsy procedure | 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. |
| Total Number of Biopsy Cores | During the biopsy procedure | The total number of biopsy cores, including MRI-targeted and systematic biopsy cores, obtained for each participant will be recorded. |
| Number of Pathology Specimen Containers | Periprocedural | The total number of pathology specimen containers generated from the biopsy procedure will be recorded for each participant. |
| Total Pathology-Related Costs | Up to 2 weeks after biopsy | 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. |
| Incidence of Biopsy-Related Adverse Events and Complications | From biopsy through 30 days after biopsy; assessed within 30 minutes, at 24 hours, day 7 (±2 days), and day 30 (±7 days) | 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. |
| Severity of Biopsy-Related Complications by Clavien-Dindo Grade | From biopsy through 30 days after biopsy | 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. |
| Change From Baseline in International Prostate Symptom Score | Baseline and 7 days after biopsy (±2 days) | 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. |
| Change From Baseline in IPSS Quality of Life Score | Baseline and 7 days after biopsy (±2 days) | 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. |
| Number of Histology Slides | Up to 2 weeks after biopsy | The total number of histology slides generated for biopsy specimen processing and pathological diagnosis will be recorded for each participant. |
Countries
China
Contacts
CONTACTHaifeng Huang
Outcome results
None listed