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

RecruitingPhase 2Ages 18 Years - anyMaleAin Shams University
NCT07693075 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

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

3 sites
Faculty of Medicine, Ain Shams University
Cairo, Egypt
Faculty of Medicine - Menoufia University
Shibฤซn al Kawm, Egypt
Faculty of Medicine - Sohag University
Sohag, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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