Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Recruiting · NCT07693075 · Interventional (participants receive a specific treatment) · Lead sponsor: Ain Shams University
View the official record on ClinicalTrials.gov →Interventions studied
Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
3 locations listed.
- Faculty of Medicine, Ain Shams University - Cairo, Egypt
- Faculty of Medicine - Menoufia University - Shibīn al Kawm, Egypt
- Faculty of Medicine - Sohag University - Sohag, Egypt