Protons Vs. Photons for High-risk 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: Proton therapy, Photon therapy.
- Кому может быть актуально
- Состояния в реестре: Prostate Cancer, Radiotherapy Side Effect. 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
- Дания
- 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
Lymph Node Radiation Therapy with Integrated Boost to Prostate for High-risk Prostate Cancer a Randomized Phase 3 Trial Comparing Photons Vs. Protons
Обзор
The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.
Подробное описание
Proton therapy (PT) is a radiation technique with possibility to spare normal pelvic organs: bladder, rectum and bowel for PC patients.
Most PC patients treated with PT receive PT to the prostate gland alone. With PT, we aim to examine PC patients in high risk with both lymph node and prostate treatment will experience less late side effects with PT compared to photon treatment.
The investigators propose a national open-labelled phase III randomized controlled trial (RCT) of proton therapy versus photon therapy of the prostate including the regional elective LN for localized/locally advanced prostate cancer patients combined with androgen deprivation therapy (ADT) aimed at 3 years. The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinical significant, measured by mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) bowel scores at 24 months and improve HRQOL. Secondary endpoints include morbidity, quality of life and survival data up to 10 years after treatment.
Вмешательства
- Лучевая терапия Proton therapy
Patients in the experimental arm will receive proton therapy within the same dose and fraction schedule as patients receiving photon therapy, which is standard treatment. - Лучевая терапия Photon therapy
Patients in the photon arm will receive standard treatment with photon therapy.
Первичные конечные точки
- Late gastrointestinal (GI) toxicity at year 2 compared to baseline using Expanded Prostate Cancer Index Composite-26 (EPIC-26) [Срок оценки: 2 years]
Вторичные конечные точки (11)
- Late Genito-urinary (GU) and sexual toxicity ≥ 2 grade at year 2 and 5 compared to baseline (Common Terminology Criteria for Adverse Events (CTCAE) toxicity score (CTC_AE 5.0) [Срок оценки: 5 years]
- Late GU and sexual toxicity at year 2, 5 and 10 compared to baseline (EPIC-26) [Срок оценки: 10 years]
- Late GI toxicity at year 5 compared to baseline (EPIC-26) [Срок оценки: 5 years]
- Acute GI at start, at the end of therapy and week 12 compared to baseline (EPIC-26) [Срок оценки: 12 weeks]
- Acute GI at start, at the end of therapy and week 12 compared to baseline (CTC_AEv.5.0) [Срок оценки: 12 weeks]
- Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (EPIC-26) [Срок оценки: 12 weeks]
- Acute GU toxicity at start, at the end of therapy and week 12 compared to baseline (CTC_AE v.5.0) [Срок оценки: 12 weeks]
- General health related quality of life (QoL) at year 2, 5 and 10 compared to baseline (EORTC QLQ-C30) [Срок оценки: 10 years]
- Biochemical progression free survival (BCR), (Phoenix criteria) [Срок оценки: 10 years]
- Non-biochemical progression free survival (by imaging) [Срок оценки: 10 years]
- Overall survival (OS) [Срок оценки: 10 years]
Критерии участия
Критерии включения
- Histologically verified localized/locally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck.
- Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%)
- Indication for elective lymph node irradiation
- PSA < 100 ng/mL
- Age ≥18 years
- Performance status 0-1
- Life expectancy ≥ 10 years
- Able to understand and comply with the treatment protocol
- No evidence of inflammatory bowel disease Ability to adhere to procedures for study and follow-up
- Signed informed consent to participate in the study
Критерии исключения
- No previous treatment for prostate cancer
- Hip-prostheses
- Other metal devices in the pelvic region (except fiducials)
- Previous major abdominal/rectal surgery
- Any other malignancy the last five years except for basal or squamous cell skin cancer
- Unable to understand patient information or comply with treatment and safety instructions
- Unable to read and understand patient information due to cognitive disabilities or language (Danish).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Дания · 7 центров
- Dept. of Oncology, Rigshospitalet, Denmark — Copenhagen
- Department of Oncology, Copenhagen University Hospital Herlev — Herlev
- Department of Oncology, Aarhus University Hospital — Aarhus
- Dept. of Oncology, Aalborg University Hospital — Aalborg
- Dept. of Oncology, Zealand University Hospital, Denmark — Næstved
- Department of Oncology, Odense University Hospital — Odense
- Department of Oncology, Vejle Hospital, Denmark — Vejle
Идентификаторы
NCT: NCT05350475 · 1-10-72-290-21