Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Balloon shield for prostate radiation: a failed promise?

NCT ID NCT02478112

Disease control Sponsor: Centre Oscar Lambret Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a temporary biodegradable balloon placed between the prostate and rectum during radiation therapy for intermediate-risk prostate cancer. The goal was to see if the balloon could reduce radiation damage to the rectum by pushing it away from the prostate. The study was terminated early, so results are limited. It involved 24 participants and focused on measuring dosimetric improvements and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

24 people

The number who actually took part.

Started

Nov 2016

Finished

Sep 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Localized adenocarcinoma of the prostate are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Clinique Pasteur

    Toulouse, 31076, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.