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Trial Title:
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
NCT ID:
NCT06599476
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
BioProtect Balloon Implant™ System
Description:
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
Arm group label:
BioProtect Balloon Implant System
Summary:
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Advanced Radiation Centers of New York
Address:
City:
New Hyde Park
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shawn Zimberg, MD
Phone:
516-394-9600
Email:
szimberg@solarishp.com
Start date:
May 21, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Advanced Radiation Centers of New York
Agency class:
Other
Source:
Advanced Radiation Centers of New York
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06599476
