← Back to all trials
Recruiting
NCT07693075
Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Conditions: Prostate Cancer Patients Treated by Radiotherapy
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: Ain Shams University
Location: Faculty of Medicine, Ain Shams University Cairo
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07693075). StuddyBuddy aggregates publicly available trial information.
