Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)

Completed

• Conditions: Prostate Cancer

• 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.

Study Timeline

• Study Start: 2020-11-09
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-19
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-24

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

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