Rectal Spacers in Prostate Cancer Radiation Therapy

This study is looking at two types of rectal spacers, SpaceOAR Vue and BioProtect Balloon Implant System, for men with localized prostate cancer who are having proton beam therapy (a type of radiation). These spacers are designed to create space between the prostate and the rectum during radiation to help protect the rectum. We want to see how much space these devices create. You may be able to join if you are over 18, have prostate cancer that hasn't spread too far, and are planning to have proton beam therapy. The study plans to enroll up to 50 participants, but the current recruitment status is unclear.

Study design
This is an interventional study with two groups, aiming to enroll up to 50 participants. It is not specified if it's randomized or blinded.
What's involved
You would have screening, spacer placement, treatment planning, an end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06594887

Rectal Spacers Use in Prostate Cancer Radiation Therapy

Recruiting
NAAges 18+InterventionalSupportive care
Princeton ProCure management, LLC.
~50 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:SpaceOAR VueBioProtect Balloon Implant System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Perirectal distance
Measured over 2-4 months
Prostate Cancer
1 sites across 1 states
New Jersey1

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  • Perirectal distance2-4 months

    Perirectal distance evaluated by measurement of the prostate-rectum separation as measured on treatment planning CT simulation.