Идёт набор NCT07693075

Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI

Фаза II С лечением Prostate Cancer Patients Treated by Radiotherapy

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: Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT).
Кому может быть актуально: Состояния в реестре: Prostate Cancer Patients Treated by Radiotherapy. 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: Египет
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

Prospective Evaluation of Efficacy and Safety of Simultaneous Integrated Boost (SIB-VMAT) Radiotherapy in HR/VHR Prostate Cancer With EPLNI

Обзор

The aim of this study is to evaluate the efficacy and safety of hypofractionated simultaneous integrated boost volumetric arc radiation therapy (SIB - VMAT) for high-risk and very high-risk localized prostate cancer in terms of: 1. Acute and late gastrointestinal and genitourinary toxicities. 2. Evaluate the efficacy in terms of early bPFS. 3. Dosimetric evaluation in terms of target coverage and organs at risk sparing

Подробное описание

Background:

Despite the overwhelming success of hypofractionation for prostate-only radiotherapy, a substantial gap in high-level evidence exists regarding its application to elective pelvic lymph node irradiation. The pivotal trials establishing the 60 Gy/20 fraction standard (such as CHHiP and PROFIT) largely excluded extensive whole pelvic nodal irradiation. Consequently, there remains a lack of definitive, prospective data validating the safety and efficacy of a hypofractionated Simultaneous Integrated Boost (SIB) technique that concurrently delivers 44 Gy to the pelvic lymph nodes and 60 Gy to the prostate over 20 fractions. While modern image-guided, Volumetric Modulated Arc Therapy (VMAT) provides the dosimetric conformity required to spare organs at risk (OARs) such as the bladder and bowel, clinical confirmation of acute and late toxicities in the context of wide-field pelvic irradiation remains paramount.

Therefore, this prospective, single-arm trial is designed to address this critical evidence gap. By rigorously evaluating the GI and GU toxicity profiles and early biochemical control, this study seeks to validate the 4-week SIB protocol as a safe, efficacious, and resource-efficient standard of care for high-risk prostate cancer requiring elective pelvic nodal irradiation.

Objectives:

To evaluate the safety of hypofractionated SIB - VMAT radiation therapy in terms of acute and late GI and GU toxicities, and also evaluate the efficacy in terms of early bPFS, and lastly, dosimetric evaluation in terms of target coverage and OAR sparing Study Arms Single arm Population: Histologically confirmed localized prostatic adenocarcinoma with high and very high risk groups.

Primary Endpoint: Acute and late GIT \& GU toxicities (according to CTCAE \& RTOG).

Secondary Endpoints:

1. To evaluate early biochemical control (serum PSA) at 6 and 12 months. 2. To perform a dosimetric analysis of target coverage and of organs at risk (OARs) dose contains.

Significance α = 0.05 two-sided; power = 80%; minimum detectable HR = 0.65 Duration 12 months total (from IRB approval to submission of the manuscript).

Вмешательства

Лучевая терапия Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)
Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk / very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days). Target volumes: PTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy/fraction), including the internal iliac, external iliac, obturator, presacral nodal station

Первичные конечные точки

Acute and late GIT & GU toxicity [Срок оценки: Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.]

Вторичные конечные точки (2)

Early biochemical progression-free survival (bPFS) [Срок оценки: Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.]
Dosimetric plan evaluation [Срок оценки: Baseline (Day 1 of radiation therapy start).]

Критерии участия

Критерии включения

Histologically confirmed adenocarcinoma of the prostate.
Classification as High-Risk (HR) or Very High-Risk (VHR) per NCCN guidelines (e.g., T3a+, PSA > 20 ng/mL, or Gleason Score 8-10).
Adequate baseline urinary function (IPSS \\le 20).
Multiparametric MRI of the prostate.
CT Chest, Abdomen, and Pelvis.
Bone scan
Optional: PSMA-PET/CT to definitively exclude distant metastases (M1) and provide high-fidelity nodal assessment prior to treatment planning.