Study Stopped
Lack of recruitment
Use of a Biodegradable Balloon for the Treatment of Prostate Cancer by Intensity Modulated Radiotherapy (BioPro-RCMI)
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)
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Nov 2016
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedStudy Start
First participant enrolled
November 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2020
CompletedMarch 17, 2026
May 1, 2019
1.5 years
June 15, 2015
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dosimetric gain from the contribution of the balloon on organs at risk
Evaluation by comparison of the dosimetric scans performed before and after the implantation of the balloon.
24 months
Secondary Outcomes (4)
Urinary and rectal toxicity
24 months
Stages of the implantation of the Bioprotect balloon
1 week
Technical feasibility of the implantation of the Bioprotect balloon
1 week
Quality of life by QLQ-C30
24 months
Study Arms (1)
Biodegradable Balloon Implant
EXPERIMENTALBiodegradable balloon implanted before radiotherapy
Interventions
Implantation under general anaesthesia of a biodegradable balloon before radiation therapy for prostate cancer
Eligibility Criteria
You may qualify if:
- Patient over 18 years old
- With a localized adenocarcinoma of the prostate
- of intermediate risk of D'AMICO
- and of stage MRI \< T3
- Requiring a treatment with Intensity Modulated Radiotherapy
- PSA (Prostate-Specific Antigen) levels ≤ 20 ng/mL before external beam radiotherapy
- Prostate volume \> 15 cc
- Short hormone therapy possibly associated (4-6 months)
- Patient without clinical signs of progressive disease (Performing a bone scan and a CT scan is optional)
- Performance status ECOG (Eastern Cooperative Oncology Group) ≤ 1
- Life expectancy ≥ 10 years
- Informed consent signed
You may not qualify if:
- Incompatibility to the implantation of a Bioprotect balloon :
- ongoing anticoagulant by vitamin K antagonist (VKA) or heparintherapy
- patient with immunosuppression or with serious chronic diseases such as heart failure, cirrhosis, chronic kidney failure, colic or rectal digestive inflammatory disease
- history of prostatitis or of lower gastrointestinal infection treated or ongoing
- history of recto-colic inflammatory disease or of repeated prostatic resections
- untreated perineal wound
- Prior treatment with hormone therapy
- History of another invasive cancer within 5 years prior to study entry (with the exception of a treated basal cell skin carcinoma)
- History of pelvic radiotherapy
- Severe hypertension non controlled by an adapted treatment (≥ 160 mm Hg in systole and/or ≥ 90 mm Hg in diastole)
- Ongoing antineoplastic therapy
- Person deprived of liberty or under tutorship
- Inability to submit to the medical monitoring of the study for geographical, social or psychological reasons.
- Conformal radiotherapy without intensity modulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- Aquilab SAScollaborator
Study Sites (1)
Clinique Pasteur
Toulouse, 31076, France
Related Publications (1)
Pasquier D, Bogart E, Bonodeau F, Lacornerie T, Lartigau E, Latorzeff I. BioPro-RCMI-1505 trial: multicenter study evaluating the use of a biodegradable balloon for the treatment of intermediate risk prostate cancer by intensity modulated radiotherapy; study protocol. BMC Cancer. 2018 May 16;18(1):566. doi: 10.1186/s12885-018-4492-5.
PMID: 29769060DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David PASQUIER, MD, PhD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2015
First Posted
June 23, 2015
Study Start
November 25, 2016
Primary Completion
May 28, 2018
Study Completion
September 7, 2020
Last Updated
March 17, 2026
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share