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

NCT07693075 | Recruiting Phase 2

• 1 other identifier: Soh-Med-26-6-12PD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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. 1.Acute and late gastrointestinal and genitourinary toxicities.
2. 2.Evaluate the efficacy in terms of early bPFS.
3. 3.Dosimetric evaluation in terms of target coverage and organs at risk sparing

Conditions

Prostate Cancer Patients Treated by Radiotherapy

Keywords

SIB-VMAT Radiotherapy; High risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• Acute and late GIT & GU toxicity

  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.

  Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.

Secondary Outcomes (2)

• Early biochemical progression-free survival (bPFS)

  Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.

• Dosimetric plan evaluation

  Baseline (Day 1 of radiation therapy start).

Study Arms (1)

SIB-VMAT radiation therapy

EXPERIMENTAL

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.

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

Interventions

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

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.

SIB-VMAT radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (3)

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

Central Study Contacts

Mohamed Alhefny, MD

CONTACT

+201228169673; Alhefny@med.asu.edu.eg

Ahmed Sohaib, MD

CONTACT

+201060406063; dr.ahmed.sohaib@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)