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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02478112
Recruitment Status : Suspended (Lack of recruitment)
First Posted : June 23, 2015
Last Update Posted : May 16, 2019
Aquilab SAS
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Biodegradable balloon implant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 25, 2016
Actual Primary Completion Date : May 28, 2018
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: BioProtect Balloon Implant System

Primary Outcome Measures :
  1. Dosimetric gain from the contribution of the balloon on organs at risk [ Time Frame: 24 months ]
    Evaluation by comparison of the dosimetric scans performed before and after the implantation of the balloon.

Secondary Outcome Measures :
  1. Urinary and rectal toxicity [ Time Frame: 24 months ]
    Urinary and rectal toxicity evaluated according to NCI-CTCAE v4.0

  2. Stages of the implantation of the Bioprotect balloon [ Time Frame: 1 week ]
    Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.

  3. Technical feasibility of the implantation of the Bioprotect balloon [ Time Frame: 1 week ]
    Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.

  4. Quality of life by QLQ-C30 [ Time Frame: 24 months ]
    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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02478112

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Institut Bergonié
Bordeaux, France, 33076
Centre Léonard de Vinci
Dechy, France, 59187
Clinique Hartmann
Levallois-Perret, France, 92309
Centre Oscar Lambret
Lille, France, 59020
Centre de Cancérologie Paris Nord
Sarcelles, France, 95200
Clinique Pasteur
Toulouse, France, 31076
Sponsors and Collaborators
Centre Oscar Lambret
Aquilab SAS
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Principal Investigator: David PASQUIER, MD, PhD Centre Oscar Lambret

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centre Oscar Lambret Identifier: NCT02478112     History of Changes
Other Study ID Numbers: BioPro-RCMI-1505
N° IdRCB : 2015-A01041-48 ( Other Identifier: ANSM )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Oscar Lambret:
Intensity Modulated Radiotherapy
Balloon implant
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases