Prospective Evaluation of a Commercially Available Hydrogel Spacer

Completed

• Conditions: Prostate Cancer

• 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.

Study Timeline

• Study Start: 2020-11-20
• Primary Completion: 2021-06-29
• Study Completion: 2022-02-08
• Study First Submitted: 2022-03-17
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-12
• Last Update Submitted: 2025-09-15
• Last Update Posted: 2025-09-16

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

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