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Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis (IBIS-PC)

27 августа 2026 г. обновлено: 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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

454

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Haifeng Huang
  • Номер телефона: +86-186-5165-8099
  • Электронная почта: 24083491@qq.com

Места учебы

  • Китай
    • Jiangsu
      • Nanjing, Jiangsu, Китай
        • Рекрутинг
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
        • Контакт:
          • Haifeng Huang
          • Номер телефона: +86-186-5165-8099

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Диагностика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Процедура: MRI/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.
Активный компаратор: 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.
Процедура: MRI/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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Detection Rate of Clinically Significant Prostate Cancer
Временное ограничение: 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%.
Day 14 after biopsy

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Prostate Cancer Detection Rate
Временное ограничение: Day 14 after biopsy
The proportion of participants with prostate cancer detected on any biopsy specimen, regardless of ISUP Grade Group.
Day 14 after biopsy
Clinically Insignificant Prostate Cancer Detection Rate
Временное ограничение: 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.
Day 14 after biopsy
High-Grade Prostate Cancer Detection Rate
Временное ограничение: Day 14 after biopsy
The proportion of participants with biopsy pathology showing ISUP Grade Group 3 or higher.
Day 14 after biopsy
Pain Numeric Rating Scale Score
Временное ограничение: 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.
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
Временное ограничение: 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.
Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort
Procedure Time
Временное ограничение: 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.
During the biopsy procedure
Total Number of Biopsy Cores
Временное ограничение: During the biopsy procedure
The total number of biopsy cores, including MRI-targeted and systematic biopsy cores, obtained for each participant will be recorded.
During the biopsy procedure
Number of Pathology Specimen Containers
Временное ограничение: Periprocedural
The total number of pathology specimen containers generated from the biopsy procedure will be recorded for each participant.
Periprocedural
Total Pathology-Related Costs
Временное ограничение: 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.
Up to 2 weeks after biopsy
Incidence of Biopsy-Related Adverse Events and Complications
Временное ограничение: 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.
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
Временное ограничение: 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.
From biopsy through 30 days after biopsy
Change From Baseline in International Prostate Symptom Score
Временное ограничение: 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.
Baseline and 7 days after biopsy (±2 days)
Change From Baseline in IPSS Quality of Life Score
Временное ограничение: 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.
Baseline and 7 days after biopsy (±2 days)
Number of Histology Slides
Временное ограничение: 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.
Up to 2 weeks after biopsy

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Real-Time Ultrasound Visibility of MRI-Suspicious Lesions
Временное ограничение: During MRI/ultrasound cognitive fusion targeted biopsy
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.
During MRI/ultrasound cognitive fusion targeted biopsy
ISUP Grade Group Concordance Between Biopsy and Radical Prostatectomy Pathology
Временное ограничение: Up to 6 months after biopsy
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.
Up to 6 months after biopsy

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Соавторы

Beijing Hospital
Nantong First People's Hospital
The First People's Hospital of Changzhou
Huai'an First People's Hospital
Northern Jiangsu People's Hospital

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

20 июля 2026 г.

Первичное завершение (Оцененный)

1 марта 2027 г.

Завершение исследования (Оцененный)

1 апреля 2027 г.

Даты регистрации исследования

Первый отправленный

5 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

27 августа 2026 г.

Первый опубликованный (Действительный)

31 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

31 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 августа 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • IUNU-PC-131
  • 2026-0723-02 (Другой идентификатор: Medical Ethics Committee of Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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