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Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Sponsor: Ain Shams University
Summary
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
Official title: Prospective Evaluation of Efficacy and Safety of Simultaneous Integrated Boost (SIB-VMAT) Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-08-01
Completion Date
2026-11-01
Last Updated
2026-07-09
Healthy Volunteers
No
Interventions
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 stations, whole prostate, and SV. PTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy/fraction), including the whole prostate and the base of the SV (proximal 1 cm). Systemic Therapy is allowed during the study when indicated. Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months. ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy.
Locations (3)
Faculty of Medicine, Ain Shams University
Cairo, Egypt
Faculty of Medicine - Menoufia University
Shibīn al Kawm, Egypt
Faculty of Medicine - Sohag University
Sohag, Egypt