Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorAin Shams University
About this trial
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
Qualifiers
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.
Disqualifiers
Prior pelvic radiotherapy.
History of Inflammatory Bowel Disease (IBD) or active severe proctitis.
Presence of distant metastases.
Trial design
Treatments tested in this trial
- Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov