NCT07693075RecruitingPhase 2
Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Prospective Evaluation of Efficacy and Safety of Simultaneous Integrated Boost (SIB-VMAT) Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 28 Jun 2026
- Start date
- Aug 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Ain Shams University
- Diseases
- Prostate cancer
- NCT number
- NCT07693075
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From Aug 2025 to the primary completion date, Sept 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy.
Other illness
- History of Inflammatory Bowel Disease (IBD) or active severe proctitis.
Other
- Presence of distant metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine-Ain Shams University Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
| Faculty of Medicine - Menoufia University Coordinator of this site? Confirm its status | Shibīn al Kawm | Egypt | Recruiting |
| Faculty of Medicine, Sohag University Coordinator of this site? Confirm its status | Sohag | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.