Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients (CLP-10095)

September 15, 2025 updated by: BioProtect

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

175

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

  • Poland
      • Warsaw, Poland
        • Institute of Maria Skłodowska, Curie (MCMCC)
  • Portugal
      • Porto, Portugal
        • Cuf Porto institution

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

Sampling Method

Probability Sample

Study Population

Prostate Cancer

Description

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

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate to rectum spacing
Time Frame: 1 month
Measurement of prostate-rectum spacing
1 month

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events throughout the treatment course and follow up period
Time Frame: 3 months
3 months

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)

June 18, 2020

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-10095

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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