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NCT05323747 Clinical Trial

Prospective Evaluation of a Commercially Available Hydrogel Spacer

Prostate Cancer Clinical Trial

— BP-008  

Official title:
Clinical Protocol for the Prospective Evaluation of a Commercially Available Hydrogel Spacer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05323747
Other study ID # BP-008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 20, 2020
Est. completion date February 8, 2022

Study information
Verified date April 2022
Source BioProtect
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Dosimetry efficacy evaluation of the hydrogel spacer

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 information / eligibility
Status Completed
Enrollment 20
Est. completion date February 8, 2022
Est. primary completion date June 29, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Assessment of rectal dosimetry change from pre-insertion to post-insertion in subjects with prostate cancer who have undergone radiotherapy with a hydrogel spacer.

Locations
Country Name City State
United States Western Radiation Oncology Campbell California
United States Northern Nevada Radiation Oncology Reno Nevada

Sponsors (1)
Lead Sponsor Collaborator
BioProtect

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dosimetry changes Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post Hydrogel Injection 1 month
Secondary Prostate to rectum spacing Prostate to rectum spacing measurement for evaluation of the perirectal distance post-hydrogel insertion 1 month
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