Could a gel spacer replace needle markers in prostate radiation?
NCT ID NCT05650021
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a special gel spacer placed near the rectum can help doctors aim radiation more accurately for prostate cancer. Seventeen men who already had the spacer and small metal markers (fiducials) were included. Doctors compared how well the gel spacer worked for daily alignment versus the standard markers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SpaceOAR Vue radiopaque hydrogel rectal spacer
- What this could lead to
- If it works, this could simplify prostate cancer radiation by removing the need for separate fiducial markers.
- What could go wrong
- This is a small, early study with only 17 participants, so results may not apply to all patients. The spacer may not align as accurately as fiducial markers.
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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17 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Sep 2025
- 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * To be eligible for the study, you must have already had SpaceOAR and fiducial markers placed before undergoing prostate radiotherapy, or you should have a plan to have them placed. * Untreated cT1 - cT3 prostate cancer Exclusion Criteria: * Extracapsular extension of prostate cancer * Prior prostatectomy
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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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Penn State Cancer Institute
Hershey, Pennsylvania, 17033, 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