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OpenTrials
Completed

NCT Number: NCT05323747

Prospective Evaluation of a Commercially Available Hydrogel Spacer

Dosimetry efficacy evaluation 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

Western Radiation Oncology, Campbell, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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 measurement for evaluation of the perirectal distance post-hydrogel insertion

Sponsors and collaborators

Lead sponsor

BioProtect

Industry

Registry information

Official study title

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

Acronym: BP-008

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Sep 16, 2025

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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