Status:

COMPLETED

Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients

Lead Sponsor:

BioProtect

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

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

Eligibility Criteria

Inclusion

  • \- Males at least 18 years of age, who have undergone radiation therapy with implantable spacers

Exclusion

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

Key Trial Info

Start Date :

June 18 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2022

Estimated Enrollment :

175 Patients enrolled

Trial Details

Trial ID

NCT05354427

Start Date

June 18 2020

End Date

January 1 2022

Last Update

September 16 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Institute of Maria Skłodowska, Curie (MCMCC)

Warsaw, Poland

2

Cuf Porto institution

Porto, Portugal