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

Centre Oscar Lambret

Status

Suspended

Conditions

Prostate Cancer

Treatments

Device: Biodegradable balloon implant

Study type

Interventional

Funder types

Other

Identifiers

NCT02478112

N° IdRCB : 2015-A01041-48 (Other Identifier)

BioPro-RCMI-1505

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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