Sharper radiation beam aims to hit High-Risk prostate cancer harder, spare healthy tissue
NCT ID NCT07693075
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This trial tests a specialized radiation technique called SIB-VMAT for men with high-risk or very high-risk localized prostate cancer. The approach delivers a higher radiation dose to the tumor while giving a standard dose to nearby lymph nodes, all in 20 sessions over four weeks. Researchers are evaluating whether this method reduces side effects and improves early cancer control compared to standard radiotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)
- What this could lead to
- If successful, this approach could offer a more effective and safer radiotherapy option for men with high-risk prostate cancer, potentially improving cancer control and quality of life.
- What could go wrong
- This is a small, early-phase study (30 participants) focused on safety and early signs of effectiveness. The technique may not prove superior to standard radiotherapy, and side effects remain a possibility.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Faculty of Medicine - Menoufia University
RECRUITINGShibīn al Kawm, Egypt
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Faculty of Medicine - Sohag University
RECRUITINGSohag, Egypt
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Faculty of Medicine, Ain Shams University
RECRUITINGCairo, Egypt
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