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)

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.

Study Overview

• Status: Suspended
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Biodegradable balloon implant

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Dechy, France, 59187
    • Centre Leonard de Vinci
  • Levallois-Perret, France, 92309
    • Clinique Hartmann
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Sarcelles, France, 95200
    • Centre de Cancerologie Paris Nord
  • Toulouse, France, 31076
    • Clinique Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Patient over 18 years old

2. With a localized adenocarcinoma of the prostate

   • of intermediate risk of D'AMICO
   • and of stage MRI < T3
3. Requiring a treatment with Intensity Modulated Radiotherapy
4. PSA (Prostate-Specific Antigen) levels ≤ 20 ng/mL before external beam radiotherapy
5. Prostate volume > 15 cc
6. Short hormone therapy possibly associated (4-6 months)
7. Patient without clinical signs of progressive disease (Performing a bone scan and a CT scan is optional)
8. Performance status ECOG (Eastern Cooperative Oncology Group) ≤ 1
9. Life expectancy ≥ 10 years
10. Informed consent signed

Exclusion Criteria:

1. 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
2. Prior treatment with hormone therapy
3. History of another invasive cancer within 5 years prior to study entry (with the exception of a treated basal cell skin carcinoma)
4. History of pelvic radiotherapy
5. Severe hypertension non controlled by an adapted treatment (≥ 160 mm Hg in systole and/or ≥ 90 mm Hg in diastole)
6. Ongoing antineoplastic therapy
7. Person deprived of liberty or under tutorship
8. Inability to submit to the medical monitoring of the study for geographical, social or psychological reasons.
9. Conformal radiotherapy without intensity modulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biodegradable Balloon Implant; Biodegradable balloon implanted before radiotherapy	Device: Biodegradable balloon implant; Implantation under general anaesthesia of a biodegradable balloon before radiation therapy for prostate cancer; Other Names: BioProtect Balloon Implant System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary and rectal toxicity	Urinary and rectal toxicity evaluated according to NCI-CTCAE v4.0	24 months
Stages of the implantation of the Bioprotect balloon	Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.	1 week
Technical feasibility of the implantation of the Bioprotect balloon	Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.	1 week
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)	24 months

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Aquilab SAS
• Investigators: Principal Investigator: David PASQUIER, MD, PhD, Centre Oscar Lambret

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2016
• Primary Completion (Actual): May 28, 2018
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Intensity Modulated Radiotherapy; Balloon implant
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BioPro-RCMI-1505; N° IdRCB : 2015-A01041-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No