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Идёт набор NCT07306741

Cognitive and Fusion Prostatic Biopsy

Без фазы С лечением Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cognitive-targeted prostate biopsy.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: Без ограничений · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cognitive Versus Image Guided Fusion Transrectal Prostatic Biopsy for the Detection of Prostate Cancer

Обзор

The goal of this study is to compare two different prostate biopsy techniques used to detect prostate cancer. These techniques are cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted transrectal biopsy (FTB). Both methods aim to improve the accuracy of prostate cancer detection by targeting suspicious areas identified on prostate imaging. This study will compare how accurately each technique detects prostate cancer, the pathological findings obtained from each biopsy method, and how operator performance may influence the procedure. The information gained from this study may help improve prostate cancer diagnosis and guide future biopsy practices.

Подробное описание

This study will be conducted in the urology department, Menoufia University, and will include biopsy-naïve patients with clinical suspicion of prostate cancer. Suspicion will be based on abnormal digital rectal examination (DRE) findings and prostate-specific antigen (PSA) levels between 4 and 20 nanograms per milliliter (ng/mL).

All eligible patients will undergo multiparametric magnetic resonance imaging (mpMRI) of the prostate using a 1.5-Tesla scanner. Imaging will be interpreted by a single experienced radiologist. Only patients with lesions scored as Prostate Imaging-Reporting and Data System (PI-RADS) category 4 or 5 will be included in the study.

Participants who meet the inclusion criteria will undergo both cognitive-targeted biopsy (CTB) and magnetic resonance imaging-ultrasound fusion-targeted biopsy (FTB) during the same biopsy session. Biopsies will be performed under local or regional anesthesia using the BK3000 ultrasound system.

The study will assess predefined procedural and pathological parameters, including histopathological findings (presence or absence of malignancy and International Society of Urological Pathology \[ISUP\] grade group), lesion location by prostate zone and orientation, serum prostate-specific antigen and prostate-specific antigen density, lesion length, and procedure duration. Procedures will be performed by two operators (surgeon 1 and surgeon 2) according to the study protocol.

No results are reported in this section. Study outcomes will be entered in the results section after study completion.

Вмешательства

  • Процедура Cognitive-targeted prostate biopsy
    Participants will undergo a cognitive-targeted prostate biopsy followed immediately by a fusion-targeted prostate biopsy during the same session.

Первичные конечные точки

  • Prostate Cancer Detection Rate Assessed by Histopathological Examination [Срок оценки: During the biopsy session]
  • Clinically Significant Prostate Cancer Detection Rate Defined by International Society of Urological Pathology Grade Group [Срок оценки: During the biopsy session]
Вторичные конечные точки (3)
  • Biopsy Procedure Time Measured in Minutes [Срок оценки: During the procedure]
  • Target Lesion Length Measured on Multiparametric Magnetic Resonance Imaging [Срок оценки: Before the biopsy procedure]
  • Procedural Metrics According to Surgeon Assignment [Срок оценки: During the biopsy procedure]

Критерии участия

Критерии включения

Biopsy-naïve patients

Prostate-specific antigen level between 4 and 20 ng/mL

Multiparametric Magnetic Resonance Imaging Prostate Imaging-Reporting and Data System score 4 or 5

Критерии исключения

Prior prostate biopsy

Prostate-specific Antigen level outside the specified range

Contraindication to Magnetic Resonance Imaging

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Египет · 2 центра
  • Menoufia university hospital urology department — Shibīn al Kawm
  • Menoufia university hospital urology department — Shibīn al Kawm

Идентификаторы

NCT: NCT07306741 · UROL 22

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗