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

Prostate Cancer Clinical Trial

Official title:

Clinical Protocol for the Retrospective Evaluation of a Commercially Available Hydrogel Spacer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423431
• Other study ID #: BP-009
• Status: Completed
• Start date: November 9, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: BioProtect
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dosimetry efficacy of the hydrogel spacer.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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	Advanced Radiation Centers of New York ("ARC")	Lake Success	New York

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 as measured post hydrogel insertion based on CT simulation scans done after hydrogel insertion	1 Month