MedTrace Logo

Use of a Biodegradable Balloon for the Treatment of Prostate Cancer by Intensity Modulated Radiotherapy (BioPro-RCMI)

NCT02478112 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-17

No results posted yet for this study

Summary

The benefit of dose escalation in radiotherapy (RT) for biochemical control of prostate cancer is a clearly established fact based on the results of different published prospective trials. This benefit, acquired with three-dimensional conformal radiation technique is counterbalanced by an increase in urinary and gastrointestinal toxicity. The joint progress of dose planning systems and multileaf collimators (MLC) technology have enabled the Intensity Modulated Radiation Therapy (IMRT). Recently the contribution of "spacers" positioned in the septum between the rectum and the prostate could improve the functional results of IMRT in terms of rectal toxicity.

The aim of the investigators study is to assess the dosimetric gain from the contribution of the implantable BioProtect balloon on organs at risk.

Conditions

Interventions

DEVICE

Biodegradable balloon implant

Implantation under general anaesthesia of a biodegradable balloon before radiation therapy for prostate cancer

Sponsors & Collaborators

  • Aquilab SAS

    collaborator UNKNOWN

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • David PASQUIER, MD, PhD · Centre Oscar Lambret

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-25
Primary Completion
2018-05-28
Completion
2020-09-07

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478112 on ClinicalTrials.gov