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Completed

NCT Number: NCT05354427

Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients

Assessment of efficacy and safety of implantable spacers when used to reduce the radiation dose delivered to the organs at risk in prostate cancer patients undergoing radiotherapy.

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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

Institute of Maria Skłodowska, Curie (MCMCC), Warsaw, Poland

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About this study

Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System

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, who have undergone radiation therapy with implantable spacers

Exclusion criteria

  • Patients whose clinical and pathological data are not available.
  • Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with 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 implantabale spacers.

Primary outcomes

  1. Evaluation of Rectal radiation Dose

    Time frame: 1 month

    Dosimetry change to organs at risk in subjects with prostate cancer who have undergone radiotherapy with implantable spacers when compared to pre-implantation values.

Secondary outcomes

  1. Prostate to rectum spacing

    Time frame: 1 month

    Measurement of prostate-rectum spacing

Other outcomes

  1. Incidence of adverse events throughout the treatment course and follow up period

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

BioProtect

Industry

Registry information

Official study title

Evaluation of Commercially Available Implantable Spacers, in Prostate Cancer Patients Undergoing Radiotherapy

Acronym: CLP-10095

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 29, 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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