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Clinical Trials in Egypt / NCT07693075
Recruiting Phase 2

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

NCT07693075 · tracked via the Priya Life Science Egypt tracker
Sponsor
Ain Shams University
Phase
Phase 2
Started
2025-08-01
Last updated
2026-07-09

Condition(s) studied

Prostate Cancer Patients Treated by Radiotherapy

Investigational drug(s) / intervention(s)

Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)

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.

Study 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

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Prior pelvic radiotherapy. * History of Inflammatory Bowel Disease (IBD) or active severe proctitis. * Presence of distant metastases.

Primary outcome measure(s)

  • Acute and late GIT & GU toxicity — Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.
    The incidence and severity of acute (during the radiation treatment and up to 3 months post-treatment) and late (after 3 months from finishing radiotherapy) gastrointestinal (GI) and genitourinary (GU) toxicities associated with the SIB-VMAT approach using CTCAE v5.0 and RTOG scale.

Trial sites (3)

FacilityCityRegionStatus
Faculty of Medicine, Ain Shams University Cairo Egypt Recruiting
Faculty of Medicine - Menoufia University Shibīn al Kawm Egypt Recruiting
Faculty of Medicine - Sohag University Sohag Egypt Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07693075 on ClinicalTrials.gov ↗ ← All trials in Egypt