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
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.
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
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.