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

Not Applicable

Suspended

• Conditions: Prostate Cancer
• Interventions: Device: Biodegradable balloon implant

• Registration Number: NCT02478112
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-23
• Study Start: 2016-11-25
• Primary Completion: 2018-05-28
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biodegradable Balloon Implant	Biodegradable balloon implant	Biodegradable balloon implanted before radiotherapy

Primary Outcome Measures

Name	Time	Method
Dosimetric gain from the contribution of the balloon on organs at risk	24 months	Evaluation by comparison of the dosimetric scans performed before and after the implantation of the balloon.

Secondary Outcome Measures

Name	Time	Method
Quality of life by QLQ-C30	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)
Stages of the implantation of the Bioprotect balloon	1 week	Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.
Urinary and rectal toxicity	24 months	Urinary and rectal toxicity evaluated according to NCI-CTCAE v4.0
Technical feasibility of the implantation of the Bioprotect balloon	1 week	Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.

Trial Locations

Locations (6)

Centre de Cancérologie Paris Nord; 🇫🇷 Sarcelles, France

Clinique Hartmann; 🇫🇷 Levallois-Perret, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Léonard de Vinci; 🇫🇷 Dechy, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Clinique Pasteur; 🇫🇷 Toulouse, France