NCT02478112

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

Multicentre Study Evaluating the Use of a Biodegradable Balloon for the Treatment of Prostate Cancer (of Intermediate Risk) by Intensity Modulated Conformal Radiotherapy (BioPro-RCMI)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients eligible for the trial and having signed their consent to participate will undergo a scan to verify the possibility of implantation of the balloon. Before and after implantation of the balloon, a dosimetric scan will be performed. Radiotherapy will be administered according to the habits of each centre : Intensity modulated radiotherapy : 2 Gy / session, 5 weekly sessions, total dose of 74-80 Gy (+/- associated with an hormone therapy). Patients will have a clinical examination : * prior to the start of treatment * once a week during the radiotherapy * at the end of the radiotherapy * and at the end of the study. They will also complete quality of life questionnaires : * prior to the start of treatment * at mid-treatment * at the end of the radiotherapy * and at 3, 6, 12 and 24 months after the end of the radiotherapy. Finally, patients will undergo a laboratory examination : * prior to the start of treatment * 3 months after the end of the radiotherapy * and then every 6 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Biodegradable balloon implant	Implantation under general anaesthesia of a biodegradable balloon before radiation therapy for prostate cancer

Timeline

• Start date: 2016-11-25
• Primary completion: 2018-05-28
• Completion: 2020-09-07
• First posted: 2015-06-23
• Last updated: 2026-03-17

Locations

1 site across 1 country: France