Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT05354427
• Lead Sponsor: BioProtect

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2020-06-18
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 175

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Rectal radiation Dose	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 Outcome Measures

Name	Time	Method
Prostate to rectum spacing	1 month	Measurement of prostate-rectum spacing

Trial Locations

Locations (2)

Cuf Porto institution; 🇵🇹 Porto, Portugal

Institute of Maria Skłodowska, Curie (MCMCC); 🇵🇱 Warsaw, Poland