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OpenTrials
Completed

NCT Number: NCT05423431

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

Dosimetry efficacy of the hydrogel spacer.

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Advanced Radiation Centers of New York ("ARC")

Lake Success, New York, 111042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Prostate to rectum spacing

    Time frame: 1 Month

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

Sponsors and collaborators

Lead sponsor

BioProtect

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2022
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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