Набор скоро начнётся NCT07574489

Whole Versus Partial Gland Boost During Prostate SBRT

Фаза II / Фаза III С лечением Prostate Cancer Prostate Adenocarcinoma

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: Prostate stereotactic body radiotherapy with whole gland boost, Prostate stereotactic body radiotherapy with DIL boost.
Кому может быть актуально: Состояния в реестре: Prostate Cancer, Prostate Adenocarcinoma. Базовые параметры: от 19 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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Официальное название

Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)

Обзор

This phase 2/3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.

Подробное описание

This is a phase 2/3 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 186 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.

In both arms, patients will receive 3625 cGy delivered to the planning target volume (PTV) over 5 fractions. In Arm A, patients will receive a boost to the prostate gland. In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI).

The primary objective is to evaluate chronic genitourinary (GU) and gastrointestinal (GI) toxicities grade 2 or higher from 6 months to 2 years post-treatment using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary objectives include evaluation of acute and chronic GU and GI toxicities using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains, as well as biochemical progression-free survival at 5 years.

Participants will be followed for up to 5 years after completion of treatment.

Вмешательства

Лучевая терапия Prostate stereotactic body radiotherapy with whole gland boost
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
Лучевая терапия Prostate stereotactic body radiotherapy with DIL boost
External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.

Первичные конечные точки

Grade 2 or Higher Chronic Genitourinary Toxicity [Срок оценки: From 6 months post-treatment to 2 years post-treatment]
Grade 2 or Higher Chronic Gastrointestinal Toxicity [Срок оценки: From 6 months post-treatment to 2 years post-treatment]

Вторичные конечные точки (5)

Biochemical Progression-Free Survival [Срок оценки: From initiation of study treatment to 5 years post-treatment]
Acute Gastrointestinal Toxicity [Срок оценки: From end of treatment to 6 months post-treatment]
Acute Genitourinary Toxicity [Срок оценки: From end of treatment to 6 months post-treatment]
Chronic Gastrointestinal Toxicity [Срок оценки: From 6 months post-treatment to 5 years post-treatment]
Chronic Genitourinary Toxicity [Срок оценки: From 6 months post-treatment to 5 years post-treatment]

Критерии участия

Критерии включения

Adults ≥19 years of age
Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered
Prostate gland volume <100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT)
PI-RADS 4 or 5 lesion seen on pre-treatment MRI
IPSS/AUA symptom score less than 16