Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis (IBIS-PC)
27 de agosto de 2026 actualizado por: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
454
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Haifeng Huang
- Número de teléfono: +86-186-5165-8099
- Correo electrónico: 24083491@qq.com
Ubicaciones de estudio
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Jiangsu
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Nanjing, Jiangsu, Porcelana
- Reclutamiento
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
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Contacto:
- Haifeng Huang
- Número de teléfono: +86-186-5165-8099
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: TB+iSB
Participants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion.
Targeted biopsy will be followed by a 6-core ipsilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on the MRI lesion side.
Local anesthesia will be administered only on the MRI lesion side.
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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.
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Comparador activo: TB+SB
Participants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion.
Targeted biopsy will be followed by a standard 12-core bilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on both sides of the prostate.
Bilateral local anesthesia will be administered.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Detection Rate of Clinically Significant Prostate Cancer
Periodo de tiempo: Day 14 after biopsy
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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%.
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Day 14 after biopsy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Prostate Cancer Detection Rate
Periodo de tiempo: Day 14 after biopsy
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The proportion of participants with prostate cancer detected on any biopsy specimen, regardless of ISUP Grade Group.
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Day 14 after biopsy
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Clinically Insignificant Prostate Cancer Detection Rate
Periodo de tiempo: Day 14 after biopsy
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The proportion of participants with biopsy pathology showing ISUP Grade Group 1 prostate cancer and no lesion with ISUP Grade Group 2 or higher.
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Day 14 after biopsy
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High-Grade Prostate Cancer Detection Rate
Periodo de tiempo: Day 14 after biopsy
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The proportion of participants with biopsy pathology showing ISUP Grade Group 3 or higher.
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Day 14 after biopsy
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Pain Numeric Rating Scale Score
Periodo de tiempo: Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain
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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.
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Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain
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Overall Discomfort Numeric Rating Scale Score
Periodo de tiempo: Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort
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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.
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Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort
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Procedure Time
Periodo de tiempo: During the biopsy procedure
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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.
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During the biopsy procedure
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Total Number of Biopsy Cores
Periodo de tiempo: During the biopsy procedure
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The total number of biopsy cores, including MRI-targeted and systematic biopsy cores, obtained for each participant will be recorded.
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During the biopsy procedure
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Number of Pathology Specimen Containers
Periodo de tiempo: Periprocedural
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The total number of pathology specimen containers generated from the biopsy procedure will be recorded for each participant.
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Periprocedural
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Total Pathology-Related Costs
Periodo de tiempo: Up to 2 weeks after biopsy
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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.
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Up to 2 weeks after biopsy
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Incidence of Biopsy-Related Adverse Events and Complications
Periodo de tiempo: From biopsy through 30 days after biopsy; assessed within 30 minutes, at 24 hours, day 7 (±2 days), and day 30 (±7 days)
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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.
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From biopsy through 30 days after biopsy; assessed within 30 minutes, at 24 hours, day 7 (±2 days), and day 30 (±7 days)
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Severity of Biopsy-Related Complications by Clavien-Dindo Grade
Periodo de tiempo: From biopsy through 30 days after biopsy
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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.
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From biopsy through 30 days after biopsy
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Change From Baseline in International Prostate Symptom Score
Periodo de tiempo: Baseline and 7 days after biopsy (±2 days)
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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.
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Baseline and 7 days after biopsy (±2 days)
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Change From Baseline in IPSS Quality of Life Score
Periodo de tiempo: Baseline and 7 days after biopsy (±2 days)
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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.
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Baseline and 7 days after biopsy (±2 days)
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Number of Histology Slides
Periodo de tiempo: Up to 2 weeks after biopsy
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The total number of histology slides generated for biopsy specimen processing and pathological diagnosis will be recorded for each participant.
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Up to 2 weeks after biopsy
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Real-Time Ultrasound Visibility of MRI-Suspicious Lesions
Periodo de tiempo: During MRI/ultrasound cognitive fusion targeted biopsy
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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.
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During MRI/ultrasound cognitive fusion targeted biopsy
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ISUP Grade Group Concordance Between Biopsy and Radical Prostatectomy Pathology
Periodo de tiempo: Up to 6 months after biopsy
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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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Up to 6 months after biopsy
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Colaboradores e Investigadores
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Publicaciones y enlaces útiles
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de julio de 2026
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2026
Publicado por primera vez (Actual)
31 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IUNU-PC-131
- 2026-0723-02 (Otro identificador: Medical Ethics Committee of Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
An individual participant data sharing plan has not yet been finalized.
Any future sharing of de-identified participant data will be considered only with approval from the sponsor and the relevant ethics committee and in accordance with applicable laws, regulations, and privacy protection requirements.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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