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Идёт набор NCT06220435

Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer

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: Ultra-hypofractionated radiotherapy regimen..
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
Швеция
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

Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)

Обзор

HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.

Подробное описание

HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study.

Specific aims of the study are:

* To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome). * To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer. * To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.

Вмешательства

  • Лучевая терапия Ultra-hypofractionated radiotherapy regimen.
    * Prostate tumor(s): 49 Gray (Gy)/7 fractions * Prostate gland: 42.7 Gy/7 fractions * Elective lymph nodes: 29.4 Gy/7 fractions * Seminal vesicles: 31.15 Gy/7 fractions

Первичные конечные точки

  • Grade 3+ Genitourinary Adverse Events [Срок оценки: start of treatment - 5 years]
Вторичные конечные точки (11)
  • Grade 2+ Genitourinary Adverse Events [Срок оценки: start of treatment - 5 years]
  • Failure-free survival [Срок оценки: consent date - 5 years]
  • Local failure-free survival [Срок оценки: enrollment date - 5 years]
  • Biochemical failure-free survival [Срок оценки: enrollment date - 5 years]
  • Cancer-specific survival [Срок оценки: enrollment date - 5 years]
  • Overall survival failure-free survival, cancer-specific survival, and overall survival [Срок оценки: enrollment date - 5 years]
  • Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival [Срок оценки: enrollment date - 5 years]
  • Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival [Срок оценки: enrollment date - 5 years]
  • Adverse Events according to CTCAE v5.0 [Срок оценки: start of treatment - 5 years]
  • Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C-30) [Срок оценки: inclusion date - 5 years]
  • Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire PR-25 (EORTC QLQ-PR25) [Срок оценки: inclusion date - 5 years]

Критерии участия

Критерии включения

  • Life expectancy >5 years
  • Age ≥18 years
  • World Health Organization (WHO) performance status 0-2
  • Histological evidence of prostate cancer
  • Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L
  • At least one Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesion on diagnostic Magnetic resonance imaging (MRI)
  • Patients must be able to comply with the protocol
  • Signed informed consent
  • Adequate laboratory findings: haemoglobin (Hb) >90 g/L, absolute neutrophil count >1.0x10\^9/l, platelets >75x10\^9/l, bilirubin <2.0 x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <2.0x ULN)

Критерии исключения

  • Regional or distant metastasis
  • Any contraindications for MRI
  • PSA >150 ng/ml
  • Previous pelvic radiotherapy
  • Prior prostate surgery including transurethral resection of the prostate (TURP)
  • Endocrine treatment (past or present)
  • Other malignancies than prostate cancer and basalioma in the past five years
  • Serious disease state that makes study inclusion and treatment unsuitable
  • Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)

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
Лечение

Центры проведения

Швеция · 2 центра
  • Region Skåne, Skåne University Hospital — Lund
  • Region Västerbotten, Umeå University Hospital — Umeå

Идентификаторы

NCT: NCT06220435 · HYPO-RT-PC boost

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗