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Rectal Spacers for Prostate Cancer

N/A
Recruiting
Research Sponsored by Advanced Radiation Centers of New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with prostate cancer ≥ 18 years of age
Patients in one of the following risk groups: T1-T3 prostate cancer with no posterior extra capsular extension, Gleason score ≤ 7
Must not have
Acute or chronic prostatitis
Metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the safety and effectiveness of using spacers around the rectum in patients with localized prostate cancer who are undergoing radiation therapy. The study will involve 150 participants and includes various visits

Who is the study for?
This trial is for up to 150 people with localized prostate cancer who are planning to have radiation therapy. Participants must be eligible for rectal spacer placement, but specific inclusion and exclusion criteria details are not provided.
What is being tested?
The study is testing the BioProtect Balloon Implant™ System as a rectal spacer in patients receiving radiation treatment for prostate cancer. It aims to evaluate its safety and effectiveness through several visits including screening, implantation, simulation, post-treatment, and follow-ups at 1, 3, and 6 months.
What are the potential side effects?
Potential side effects of the BioProtect Balloon Implant™ System may include discomfort or complications related to the implant procedure itself or interactions with radiation therapy; however, specific side effects are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older with prostate cancer.
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My prostate cancer is in the early stages and not aggressive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have inflammation of the prostate.
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My cancer has spread to other parts of my body.
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I currently have a urinary tract infection.
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I am being treated with steroids for my inflammatory bowel disease.
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I have been treated for prostate cancer before.
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I have had my prostate completely removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Dosimetry

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: BioProtect Balloon Implant SystemExperimental Treatment1 Intervention
The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone

Find a Location

Who is running the clinical trial?

Advanced Radiation Centers of New YorkLead Sponsor
~96 spots leftby Aug 2025
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