Идёт набор NCT06331013

CyberKnife Ultra-hypofractionated SBRT for 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: CyberKnife ultra-hypofractionated SBRT.
Кому может быть актуально: Состояния в реестре: Prostate Cancer. Базовые параметры: 18 лет — 80 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: Италия
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

CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr With Dose-escalation to the Dominant Intraprostatic Lesion: is the Juice Worth the Squeeze? The PRO-SPEED Trial

Обзор

This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients.

Подробное описание

The patient to be enrolled in the prospective observational phase will be screened at first visit; prescription of Prostate Specific Antigen (PSA) and testosterone analysis, uroflowmetry and multiparametric Magnetic Resonance Imaging (mpMRI) are mandatory if not already done.

Additional staging imaging (computed tomography (CT) and/or bone scan) will be required according to National Comprehensive Cancer Network (NCCN) category risk group.

Subsequently, for the eligible patient, the enrollment phase involves eco-guided transrectal insertion of 3-4 gold fiducials in the prostate gland.

CT with full bladder and empty rectum will be done after 7-10 days from fiducials insertion; CyberKnife-Stereotactic Body Radiation Therapy (SBRT) treatment will start after 5-7 days from the simulation CT. A total of 36.25 Gy to the prostate gland will be executed in 5 alternate days. For each treatment delivery, the patient is required to be prepared in roughly the same bladder and rectum filling condition of the simulation day. Finally, in the last treatment day QoL and both clinician- and patient-reported genitourinary (GU) and gastrointestinal (GI) acute toxicity assessment is required.

Вмешательства

Лучевая терапия CyberKnife ultra-hypofractionated SBRT
CyberKnife ultra-hypofractionated SBRT for localized Prostate cancer with dose-escalation to the dominant intraprostatic lesion

Первичные конечные точки

Number of Participants with Acute GU and GI toxicities (RTOG) [Срок оценки: 3 months]
Number of Participants with Late GU and GI toxicities (RTOG) [Срок оценки: 24 months]
Evaluation of patient-reported toxicity [Срок оценки: 24 months]
Evaluation of patient-reported quality of life [Срок оценки: 24 months]

Критерии участия

Критерии включения

Age > 18 and < 80 years
Histologically confirmed adenocarcinoma of the prostate
Low, Intermediate and high-risk category according to NCCN version 02.2021
Clinically node negative and no distant metastasis
Eastern Cooperative Oncology Group (ECOG) Performance Status <2
Good urinary flow (peak flow >10 mL/s) or IPSS < 15
Prostate volume < 100 cc
Available mpMRI of the prostate
Less than 3 DILs at mpMRI (if >2 DILs, only DILs with higher Prostate Imaging - Reporting and Data System (PIRADS) will be included and only PI-RADS >2)
Written informed consent for treatment and research purpose