Идёт набор NCT04083937

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

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: Hypofractionated radiotherapy with photons, Hypofractionated radiotherapy with protons, Normofractionated radiotherapy with photons.
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: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an "adjuvant" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation. The current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.

Вмешательства

Лучевая терапия Hypofractionated radiotherapy with photons
hypofractionated radiotherapy with photons (total dose 57.0 Gray in 19 fractions)
Лучевая терапия Hypofractionated radiotherapy with protons
hypofractionated radiotherapy with protons (total dose 57.0 Gray relative biological effectiveness (RBE) in 19 fractions)
Лучевая терапия Normofractionated radiotherapy with photons
normofractionated radiotherapy with photons (total dose 70.0 Gray in 35 fractions)

Первичные конечные точки

Quality of life (prostate-associated, 12 weeks vs baseline) [Срок оценки: 12 weeks]

Вторичные конечные точки (5)

biochemical progression-free survival (bPFS) [Срок оценки: 5 years after baseline]
overall survival (OS) [Срок оценки: 5 years after baseline]
Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years [Срок оценки: 2 and 5 years after baseline]
Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline) [Срок оценки: 2 and 5 years after baseline]
Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline) [Срок оценки: 2 and 5 years after baseline]

Критерии участия

Критерии включения

histology-proven prostate cancer with Gleason Score and PSA-value;
indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
Karnofsky-Index ≥ 70%
age ≥ 18 years