Balloon shield may reduce radiation damage in prostate cancer treatment
NCT ID NCT06599476
First seen Jun 27, 2026 · 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, 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.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2027
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with prostate cancer ≥ 18 years of age. 2. Patients are in one of the following risk groups: * T1-T3 prostate cancer with no posterior extra capsular extension * Gleason score ≤ 7 3. Planned for radiation treatment with rectal spacer. 4. Ability to understand and the willingness to sign a written informed consent form. Exclusion Criteria: 1. Metastatic disease. 2. Previously treated localized adenocarcinoma of the prostate. 3. Active Inflammatory bowel disease requiring treatment with steroids. 4. Prior total prostatectomy. 5. Current urinary tract infection. 6. Acute or chronic prostatitis.
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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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains