Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)
Completed
- Conditions
- Prostate Cancer
- Interventions
- Other: Observation
- Registration Number
- NCT05423431
- Lead Sponsor
- BioProtect
- Brief Summary
Dosimetry efficacy of the hydrogel spacer.
- Detailed Description
Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in up to 20 males who underwent radiotherapy treatment for prostate cancer. Study utilized pre and post gel insertion CT images to determine endpoints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 19
Inclusion Criteria
- Males
- At least 18 years of age
- Undergone external beam or brachy radiation therapy with a hydrogel spacer in place
Exclusion Criteria
- Clinical and pathological data are not available
- Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radiation with Hydrogel Spacer Observation Males at least 18 years of age, who underwent radiation therapy with a hydrogel spacer in place.
- Primary Outcome Measures
Name Time Method Dosimetry Changes 1 Month Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post hydrogel injection
- Secondary Outcome Measures
Name Time Method Prostate to rectum spacing 1 Month Prostate to rectum spacing as measured post hydrogel insertion based on CT simulation scans done after hydrogel insertion
Trial Locations
- Locations (1)
Advanced Radiation Centers of New York ("ARC")
🇺🇸Lake Success, New York, United States