Rectal Spacers Use in Prostate Cancer Radiation Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT06594887
- Lead Sponsor
- Princeton ProCure management, LLC.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Perirectal distance 2-4 months Perirectal distance evaluated by measurement of the prostate-rectum separation as measured on treatment planning CT simulation.
- Secondary Outcome Measures
Name Time Method Spacer stability over time 2-4 months Evaluated by spacer's height (mm) measurements taken at the last radiation treatment day.
Mean rectal dose 2-4 months Spacers effect on the exposure of the rectum to radiation (rV 70)
Trial Locations
- Locations (1)
Procure Proton Therapy Center
🇺🇸Somerset, New Jersey, United States
Procure Proton Therapy Center🇺🇸Somerset, New Jersey, United StatesHeba DarwishContactheba.darwish@procure.com