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

RECRUITINGPhase 2Sponsored by Ain Shams University
Actively Recruiting
PhasePhase 2
SponsorAin Shams University
Started2025-08-01
Est. completion2026-09-01
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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.

Conditions2

CancerProstate Cancer Patients Treated by Radiotherapy

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