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

Primary Purpose

Prostate Cancer

Status

Suspended

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Biodegradable balloon implant

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Intensity Modulated Radiotherapy, Balloon implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Institut Bergonié
Centre Léonard de Vinci
Clinique Hartmann
Centre Oscar Lambret
Centre de Cancérologie Paris Nord
Clinique Pasteur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biodegradable Balloon Implant

Arm Description

Biodegradable balloon implanted before radiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Urinary and rectal toxicity

Urinary and rectal toxicity evaluated according to NCI-CTCAE v4.0

Stages of the implantation of the Bioprotect balloon

Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.

Technical feasibility of the implantation of the Bioprotect balloon

Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.

Quality of life by QLQ-C30

Quality of life measured by the QLQ-C30 questionnaire of the EORTC (European Organisation for Research and Treatment of Cancer) and by the QLQ-C30 PR25 module and the International Prostate Symptom Score (IPSS)

Full Information

NCT ID

NCT02478112

First Posted

June 15, 2015

Last Updated

May 14, 2019

Sponsor

Centre Oscar Lambret

Collaborators

Aquilab SAS

1. Study Identification

Unique Protocol Identification Number

NCT02478112

Brief Title

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

Acronym

BioPro-RCMI

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Suspended

Why Stopped

Lack of recruitment

Study Start Date

November 25, 2016 (Actual)

Primary Completion Date

May 28, 2018 (Actual)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Oscar Lambret

Collaborators

Aquilab SAS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Intensity Modulated Radiotherapy, Balloon implant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biodegradable Balloon Implant

Arm Type

Experimental

Arm Description

Biodegradable balloon implanted before radiotherapy

Intervention Type

Device

Intervention Name(s)

Biodegradable balloon implant

Other Intervention Name(s)

BioProtect Balloon Implant System

Intervention Description

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

Primary Outcome Measure Information:

Title

Dosimetric gain from the contribution of the balloon on organs at risk

Description

Evaluation by comparison of the dosimetric scans performed before and after the implantation of the balloon.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Urinary and rectal toxicity

Description

Urinary and rectal toxicity evaluated according to NCI-CTCAE v4.0

Time Frame

24 months

Title

Stages of the implantation of the Bioprotect balloon

Description

Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.

Time Frame

1 week

Title

Technical feasibility of the implantation of the Bioprotect balloon

Description

Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.

Time Frame

1 week

Title

Quality of life by QLQ-C30

Description

Time Frame

24 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David PASQUIER, MD, PhD

Organizational Affiliation

Centre Oscar Lambret

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Bergonié

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Centre Léonard de Vinci

City

Dechy

ZIP/Postal Code

59187

Country

France

Facility Name

Clinique Hartmann

City

Levallois-Perret

ZIP/Postal Code

92309

Country

France

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

Centre de Cancérologie Paris Nord

City

Sarcelles

ZIP/Postal Code

95200

Country

France

Facility Name

Clinique Pasteur

City

Toulouse

ZIP/Postal Code

31076

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29769060

Citation

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.

Results Reference

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

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