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Patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria will be eligible to participate on this study.
This is a randomized, two arm study for patients with low-risk or favorable intermediate-risk prostate cancer as defined by 1.2016 NCCN criteria.
Patients will be randomized to either rectal spacer placement or endorectal balloon placement, daily prior to each radiation treatment.
1. Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.
2. Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.
This study plans to enroll a total of 40 patients with an accrual period of 4 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Endorectal Balloon, Rectal Spacer, Radiation therapy
Weill Cornell Medicine
Weill Medical College of Cornell University
Published on BioPortfolio: 2016-09-22T20:53:21-0400
Placement of rectal spacer followed by Stereotactic Ablative Radiotherapy (SABR): 5 fractions (9 Gy per fraction) for a total of 45 Gy
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Nonoperative repair of occluded vessels, ducts, or valves by insertion of a balloon catheter. It is used, among other things, to treat varices, torn retinas, renal and biliary calculi, gastric, bronchial and rectal stenoses, and heart valves, and includes catheterization with Fogarty and Foley CATHETERS.
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