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Rectal Spacers for Prostate Cancer

N/A
Recruiting
Research Sponsored by Princeton ProCure management, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gleason Score less than or equal to 7
Subjects greater than 18 years old with prostate cancer
Must not have
Active urinary tract infection
Planned Pelvic lymph node radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial will test the use of rectal spacers in patients with localized prostate cancer who will undergo Proton Beam Therapy. They will enroll up to 50 participants and follow them for up to

Who is the study for?
This trial is for up to 50 people with localized prostate cancer who are planning to undergo Proton Beam Therapy. Participants will be monitored from spacer placement through treatment and up to a 6-month follow-up.
What is being tested?
The study is testing two types of rectal spacers: BioProtect Balloon Implant System and SpaceOAR Vue, in patients receiving PBT, comparing their effectiveness and outcomes during the course of treatment.
What are the potential side effects?
Potential side effects may include discomfort or pain where the spacer is placed, possible infection risk, bleeding, or rectal issues due to the implant procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has a Gleason Score of 7 or less.
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I am over 18 years old and have prostate cancer.
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My prostate cancer was confirmed by a biopsy within the last year, and I am scheduled for proton beam therapy with a rectal spacer.
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My prostate cancer is in an early stage and has not spread beyond the prostate capsule.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have a urinary tract infection.
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I am scheduled for radiotherapy targeting the lymph nodes in my pelvis.
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My cancer has spread to other parts of my body.
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I am currently being treated with steroids for my inflammatory bowel disease.
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I have had treatment for prostate cancer that was aimed at the prostate only.
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I have had surgery to remove my prostate.
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I have inflammation or infection in my prostate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Perirectal distance
Secondary study objectives
Mean rectal dose
Spacer stability over time

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: SpaceOAR VueExperimental Treatment1 Intervention
Group II: BioProtect Balloon Implant SystemExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Princeton ProCure management, LLC.Lead Sponsor
~33 spots leftby Sep 2025
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