Simultaneous Integrated Boost Radiotherapy for High- and Very High-Risk Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, single-arm trial evaluating hypofractionated simultaneous integrated boost radiotherapy using VMAT for high-risk and very high-risk localized prostate cancer. The regimen delivers 44 Gy to the pelvic lymph nodes and 60 Gy to the prostate over 20 fractions, with a focus on acute and late GI/GU toxicities, early biochemical progression-free survival, and dosimetric target coverage and organ-at-risk sparing. Eligibility includes histologically confirmed prostate adenocarcinoma, HR/VHR per NCCN, adequate baseline urinary function, and requisite imaging studies to stage disease. Primary outcomes center on safety and early efficacy, while secondary considerations include treatment planning feasibility and quality-of-life considerations related to pelvic irradiation. The trial is prospective, open-label, and single-arm, conducted under Ain Shams University with collaboration from affiliated Egyptian institutions.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Mohamed Alhefny, MD
• Email: Alhefny@med.asu.edu.eg
• Phone: +201228169673

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.