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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer Patients Treated by Radiotherapy

In brief

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

Key facts

Study ID

NCT07693075

Run by

Ain Shams University

People needed

30

Starts

2025-08-01

Expected to finish

2026-11-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Prior pelvic radiotherapy.
• History of Inflammatory Bowel Disease (IBD) or active severe proctitis.
• Presence of distant metastases.

Where it is running

• Faculty of Medicine, Ain Shams University — Cairo, Egypt (enrolling)
• Faculty of Medicine - Menoufia University — Shibīn al Kawm, Egypt (enrolling)
• Faculty of Medicine - Sohag University — Sohag, Egypt (enrolling)

Full record on ClinicalTrials.gov

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