Balloon shield may reduce radiation damage in prostate cancer treatment
NCT ID NCT06599476
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tests a biodegradable balloon, called a rectal spacer, placed between the prostate and rectum before radiation therapy for prostate cancer. The goal is to see if it safely reduces radiation exposure to the rectum, potentially lowering side effects. Up to 150 men with localized prostate cancer will be followed for two years after treatment.
What this could mean
Our plain-language read of the trial. This is informational only โ not medical advice or a prediction.
- Active substance
- BioProtect Balloon Implant System (a biodegradable balloon placed between the prostate and rectum)
- What this could lead to
- If it works, this could make radiation therapy for prostate cancer safer by reducing damage to the rectum, leading to fewer side effects.
- What could go wrong
- This is a single-group study without a comparison group, so it's unclear if the spacer is better than standard care. The balloon insertion also carries a small risk of infection or discomfort.
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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.
Contacts and locations
Locations
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Advanced Radiation Centers of New York
New Hyde Park, New York, 11042, United States
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