Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study
Princeton ProCure management, LLC.
Summary
This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study. Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria 1. Subjects greater than 18 years old with prostate cancer 2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer 3. Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer 4. PSA less than or equal to 20 ng/mL 5. Gleason Score less than or equal to 7 6. Capacity to comprehend and readiness to sign a written informed consent form Exclusion Criteria 1. Planned Pelvic lymph node radiotherapy. 2. Met…
Interventions
- DeviceSpaceOAR Vue
Peri-rectal hydrogel spacer consists of a layer of polyethylene-glycol gel (SpaceOAR vue) in order to outdistance the prostate from anterior rectal wall
- DeviceBioProtect Balloon Implant System
The balloon spacer is a biodegradable balloon made of poly (L-Lactide-co-caprolactone) which is a co-polymer of Poly Lactide acid and epsilon Caprolactone (BioProtect Balloon Implant System, BioProtect Ltd) inflated with saline, providing around 18 mm space height , and can be deflated and repositioned if needed, both laterally and along the distal /proximal planes, for optimal uniformity of spacing.
Location
- Procure Proton Therapy CenterSomerset, New Jersey