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

BioProtect19 enrolled

Overview

Dosimetry efficacy of the hydrogel spacer.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

ObservationOTHER

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Advanced Radiation Centers of New York ("ARC")

Lake Success, New York, United States

Outcomes

Primary Outcomes

Dosimetry Changes

Assessment of rectal radiation exposure as compared between rectal dose volume histograms calculated for pre and post hydrogel injection

Time frame: 1 Month

Secondary Outcomes

Prostate to rectum spacing

Prostate to rectum spacing as measured post hydrogel insertion based on CT simulation scans done after hydrogel insertion

Time frame: 1 Month

Data from ClinicalTrials.gov

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