Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With … (NCT07693075) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI
Egypt30 participantsStarted 2025-08-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute and late GIT & GU toxicity
Timeframe: Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.