Prospective Evaluation of a Commercially Available Hydrogel Spacer (BP-008)

April 5, 2022 updated by: BioProtect

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

Dosimetry efficacy evaluation of the hydrogel spacer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Campbell, California, United States, 95008
        • Western Radiation Oncology
    • Nevada
      • Reno, Nevada, United States, 89521
        • Northern Nevada Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Prostate Cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiation with Hydrogel Spacer
Males at least 18 years of age, who will be undergoing radiation therapy with a hydrogel spacer in place.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetry changes
Time Frame: 1 month
Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post Hydrogel Injection
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate to rectum spacing
Time Frame: 1 month
Prostate to rectum spacing measurement for evaluation of the perirectal distance post-hydrogel insertion
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioProtect

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

February 8, 2022

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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