Идёт набор NCT05109910

The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

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: Pelvic lymph node dissection.
Кому может быть актуально: Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 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: Нидерланды
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

Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Обзор

An extended pelvic lymph node dissection (ePLND) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (PCa) patients. The therapeutic value, however remains unclear. Prospective randomized trials to address this void are lacking. Since in intermediate and a proportion of high risk PCa the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity. Therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk PCa patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (RP) with or without an ePLND.

Подробное описание

The role of an extended pelvic lymph node dissection (ePLND) in patients undergoing radical prostatectomy (RP) remains controversial. An ePLND is the most accurate staging method to assess the presence of lymph node metastases. Lymph node involvement is associated with a significantly worse prognosis and may require immediate or delayed adjuvant therapy. However, an ePLND is associated with an increased risk of complications such as lymphoceles, thromboses and lymphedema, and prolongs surgery and patient recovery. Thus, the diagnostic advantage of PLND should be weighed against the potential morbidity.

The therapeutic value of an ePLND remains especially unclear in PCa patients with an estimated risk of lymph node invasion (LNI) ≤ 20%, where only a minority of patients will have nodes harbouring metastases. Prospective trials to address this issue are still lacking.

Вмешательства

Процедура Pelvic lymph node dissection
Bilateral extended pelvic lymph node dissection

Первичные конечные точки

Persistent PSA rate [Срок оценки: 6 months after surgery]

Вторичные конечные точки (9)

Biochemical recurrence (BCR) rate [Срок оценки: 3 years after surgery]
Metastasis-free survival [Срок оценки: 3 years after surgery]
Incidence of complications after surgery [Срок оценки: 3 and 6 months after surgery]
Incidence of salvage therapy after primary surgery [Срок оценки: 3 years after surgery]
Global Quality of life after surgery [Срок оценки: 6, 12, 24 and 36 months after surgery]
Health-related quality of life of patients with prostate cancer [Срок оценки: 6, 12, 24 and 36 months after surgery]
Urinary continence after surgery [Срок оценки: 6, 12, 24 and 36 months after surgery]
Urinary voiding symptoms [Срок оценки: 6, 12, 24 and 36 months after surgery]
Potency after surgery [Срок оценки: 6, 12, 24 and 36 months after surgery]

Критерии участия

Критерии включения

Male, aged ≥ 18 years
Prostate cancer patients with a Briganti calculated risk of LN metastases of 5-20% without evidence of metastases on Prostate-Specific Membrane Antigen (PSMA) PET/CT requiring an ePLND in the standard treatment
Scheduled for a (robot-assisted) laparoscopic radical prostatectomy
Written informed consent