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

Prostate Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02478112
• Other study ID #: BioPro-RCMI-1505
• Secondary ID: N° IdRCB : 2015-
• Status: Suspended
• Phase: N/A
• Start date: November 25, 2016
• Est. completion date: January 2021

Study information

• Verified date: May 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. completion date: January 2021
• Est. primary completion date: May 28, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Biodegradable balloon implant
Implantation under general anaesthesia of a biodegradable balloon before radiation therapy for prostate cancer

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Centre Léonard de Vinci	Dechy
France	Clinique Hartmann	Levallois-Perret
France	Centre Oscar Lambret	Lille
France	Centre de Cancérologie Paris Nord	Sarcelles
France	Clinique Pasteur	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Aquilab SAS

Country where clinical trial is conducted

France, 

Outcome

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