Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis (IBIS-PC)
27 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
454
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Haifeng Huang
- Número de telefone: +86-186-5165-8099
- E-mail: 24083491@qq.com
Locais de estudo
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Jiangsu
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Nanjing, Jiangsu, China
- Recrutamento
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
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Contato:
- Haifeng Huang
- Número de telefone: +86-186-5165-8099
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Detection Rate of Clinically Significant Prostate Cancer
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall Prostate Cancer Detection Rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Real-Time Ultrasound Visibility of MRI-Suspicious Lesions
Prazo: 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
Prazo: 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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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de julho de 2026
Conclusão Primária (Estimado)
1 de março de 2027
Conclusão do estudo (Estimado)
1 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
5 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de agosto de 2026
Primeira postagem (Real)
31 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de agosto de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IUNU-PC-131
- 2026-0723-02 (Outro identificador: Medical Ethics Committee of Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
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