Prospective Evaluation of a Commercially Available Hydrogel Spacer
Completed
- Conditions
- Prostate Cancer
- Interventions
- Other: Observation
- Registration Number
- NCT05323747
- Lead Sponsor
- BioProtect
- Brief Summary
Dosimetry efficacy evaluation of the hydrogel spacer
- Detailed Description
Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- Males
- At lease 18 years of age
- Undergoing external beam or brachy radiation therapy with a hydrogel spacer
Exclusion Criteria
- 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 will be undergoing 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 measurement for evaluation of the perirectal distance post-hydrogel insertion
Trial Locations
- Locations (2)
Western Radiation Oncology
🇺🇸Campbell, California, United States
Northern Nevada Radiation Oncology
🇺🇸Reno, Nevada, United States