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Набор по приглашению NCT03648359

Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance

Без фазы С лечением Prostatic Neoplasms

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: multiparametric MRI Diagnostics.
Кому может быть актуально
Состояния в реестре: Prostatic Neoplasms. Базовые параметры: 18 лет — 75 лет · 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring

Подробное описание

Men with localized prostate cancer (PCa) with small tumor burden may be followed on active surveillance (AS) rather than active treatment. AS is an attempt to avoid over-treatment of PCa, which is estimated to be insignificant at the time of diagnosis, and therefore unlikely to affect patient morbidity and mortality. AS include close monitoring with PSA measurement (blood test), digital rectal exploration (DRE) and trans-rectal ultrasound-guided prostate biopsy (TRUS-bx) at regular intervals, so that active treatment can be initiated if the cancer becomes more aggressive. It is crucial that patients undergoing AS are staged correctly, to avoid underestimating more aggressive disease and patients mistakenly are enrolled into AS instead of active treatment.

Previously, a PhD study conducted at Herlev Hospital revealed that multiparametric MRI (mp-MRI) of the prostate can improve the detection and staging of PCa and may add additional information about tumor aggressiveness compared to the traditional methods DRE and TRUS-bx. Mp-MRI at the inclusion of AS may detect missed significant tumors and potential areas of higher aggressiveness than detected by the traditional biopsies. Additional targeted biopsies from these suspicious areas can then be performed with a re-evaluation of the treatment plan, if more advanced disease is identified. Conversely, mp-MRI has a high negative predicted value for significant disease and can be used to rule out significant PCa, reassuring patients and physicians to go on with AS. Mp-MRI has been used at the Urology Department, Herlev Hospital, since 2013 in the diagnosis of PCa and in the evaluation of patients undergoing AS. A retrospective study have show that mp-MRi improve the detection of missed significant PCa.

The main objective of this study is now to prospectively investigate, whether mp-MRI can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Вмешательства

  • Процедура multiparametric MRI Diagnostics
    Patients with newly diagnosed prostate cancer enrolled in active surveillance following standard protocol including PSA, DRE and TRUS biopsies and intervention with multiparametric MRI + additional biopsies if suspicious lesions are found

Первичные конечные точки

  • Changes in treatment from active surveillance (observation) to active treatment based on mp-MRI results. [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Patients with low risk localized prostate cancer enrolled in active surveillance

Критерии исключения

  • Metastatic prostate cancer
  • No mp-MRI data present
  • Prostate cancer treatment
  • Known allergic reaction to Gadolinium-based MRI contrast agent
  • Prostate biopsy during the last 21 days
  • Impaired renal function with GFR < 30 ml / min
  • pacemaker
  • Magnetic metal residues in the body
  • Claustrophobia
  • Psychiatric disorders
  • Age under 18 year

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Дания · 1 центр
  • Department of Urology, Herlev University Hospital Herlev — Herlev

Идентификаторы

NCT: NCT03648359 · AS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗