Prostate CancerBioPro-RCMINCT02478112
Use of a Biodegradable Balloon for the Treatment of Prostate Cancer by Intensity Modulated Radiotherapy (BioPro-RCMI)
A study testing Biodegradable balloon implant in people with Prostate Cancer, run by Centre Oscar Lambret at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Biodegradable balloon implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2016to 7 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Biodegradable balloon implant
- Keywords
- Intensity Modulated Radiotherapy, Balloon implant
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable balloon implantDevice
Also called BioProtect Balloon Implant System
Implantation under general anaesthesia of a biodegradable balloon before radiation therapy for prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Biodegradable Balloon Implant | Experimental | Biodegradable balloon implanted before radiotherapy Receives: Device: Biodegradable balloon implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
Urinary and rectal toxicity
Urinary and rectal toxicity evaluated according to NCI-CTCAE v4.0
Measured: 24 months
Stages of the implantation of the Bioprotect balloon
Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.
Measured: 1 week
Technical feasibility of the implantation of the Bioprotect balloon
Monitoring of the balloon by Cone Beam Computed Tomography during the radiotherapy.
Measured: 1 week
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start25 Nov 2016
- Primary completion28 May 2018
- Study completion7 Sep 2020
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Aquilab SAS
- Responsible party
- Sponsor
- Investigators
- David PASQUIER, MD, PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478112
- Sponsor's protocol ID
- BioPro-RCMI-1505
- Other IDs
- N° IdRCB : 2015-A01041-48
- Acronym
- BioPro-RCMI
- Status last verified
- May 2019
- First submitted
- 15 Jun 2015
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pasquier D, Bogart E, Bonodeau F, Lacornerie T, Lartigau E, Latorzeff I. BioPro-RCMI-1505 trial: multicenter study evaluating the use of a biodegradable balloon for the treatment of intermediate risk prostate cancer by intensity modulated radiotherapy; study protocol. BMC Cancer. 2018 May 16;18(1):566. doi: 10.1186/s12885-018-4492-5.
PubMed 29769060
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02478112
- Acronym / sponsor ID
- BioPro-RCMI / BioPro-RCMI-1505
- Conditions
- Prostate Cancer
- Keywords
- Intensity Modulated Radiotherapy, Balloon implant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Aquilab SAS
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 28 May 2018 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biodegradable Balloon Implant | Experimental | Device: Biodegradable balloon implantBiodegradable balloon implanted before radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient over 18 years old
- With a localized adenocarcinoma of the prostate
- Requiring a treatment with Intensity Modulated Radiotherapy
- PSA (Prostate-Specific Antigen) levels ≤ 20 ng/mL before external beam radiotherapy
- Prostate volume > 15 cc
Key exclusion criteria (14 listed)
- Incompatibility to the implantation of a Bioprotect balloon :
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodegradable balloon implantAlso: BioProtect Balloon Implant SystemImplantation under general anaesthesia of a biodegradable balloon before radiation therapy for prostate cancer | Device | Biodegradable Balloon Implant |
Primary outcome
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.
4 secondary outcomes
Urinary and rectal toxicity
Time frame: 24 months
Stages of the implantation of the Bioprotect balloon
Time frame: 1 week
Technical feasibility of the implantation of the Bioprotect balloon
Time frame: 1 week
Quality of life by QLQ-C30
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Derived from this study: PubMed 29769060Pasquier D, Bogart E, Bonodeau F, Lacornerie T, Lartigau E, Latorzeff I. BioPro-RCMI-1505 trial: multicenter study evaluating the use of a biodegradable balloon for the treatment of intermediate risk prostate cancer by intensity modulated radiotherapy; study protocol. BMC Cancer. 2018 May 16;18(1):566. doi: 10.1186/s12885-018-4492-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David PASQUIER, MD, PhD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodegradable balloon implant in people with Prostate Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetric gain from the contribution of the balloon on organs at risk (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02478112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.