Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
Conditions
Prostate CancerSummary
This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.Study visits:* Screening * Spacer placement * Treatment planning simulation * End of the radiation treatment * 1,3,and 6-months FU visits.
Locations
1 location Found with status Recruiting
Eligibility Criteria
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.
Study Plan
BioProtect Balloon Implant System
EXPERIMENTAL
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
DEVICE:
BioProtect Balloon Implantu2122 SystemDescription:
The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time
Outcome Measures
Primary Outcome Measures
Dosimetry
Timeline
Last Updated
September 19, 2024Start Date
September 19, 2024Today
January 16, 2025Completion Date ( Estimated )
December 1, 2025
Sponsors of this trial
Lead Sponsor
Advanced Radiation Centers of New York