Идёт набор NCT04797039

MRI-Guided Cryoablation for Focal Native Prostate Cancer

— Наблюдательное Primary Malignant Neoplasm of Prostate (Diagnosis)

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: MR guided cryoablation.
Кому может быть актуально: Состояния в реестре: Primary Malignant Neoplasm of Prostate (Diagnosis). Базовые параметры: 30 лет — 100 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed. Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.

Подробное описание

The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system. The system has been approved by the United States Food and Drug Administration (FDA) for soft tissue ablation and has been utilized successfully at Mayo. All procedures will be performed according to approved indications. the investigators wish to monitor the technique and collect data at the participants follow-up visits.

The study only collects data about the MRI-guided cryoablation procedure the participants doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed. The participants doctor will advise the participants when the participants should return for follow-up visits. These visits will be according to the participants doctor's standard of care; usually return visits are at 3-6months, 12 months, 24 months, 36 months, 48 months and 60 months after the procedure, although the participants doctor may ask that the participants return for more frequent visits.

Вмешательства

Процедура MR guided cryoablation
MR guided cryoablation of focal biopsy proven prostate cancer

Первичные конечные точки

Technical success of the MR-guided cryoablation [Срок оценки: Will assess for 5 years with interval assessment each year]
Safety of the MR-guided cryoablation [Срок оценки: Will assess for 5 years with interval assessment each year]
Examine short term tumor recurrence [Срок оценки: Will assess for 5 years with interval assessment each year]

Вторичные конечные точки (1)

MR procedure time. [Срок оценки: Will assess for 5 years with interval assessment each year]

Критерии участия

Критерии включения

Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment
Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment
Tumor size is < 2 cm at its largest diameter
Tumor does not encompass the rectal wall or external urethral sphincter
Patient is able to undergo MRI