Prostate CancerMURIELLENCT02050542

Study of Current Practice Which Compare the Rate of Prostate Cancer by Using 2 Kind of Transrectal Biopsies: 3 by IRM-echography Image Fusion and 12 Systematized Guided Echographies.

A study testing systematic biopsies and Targeted biopsies guided by a fusion of MRI and ultrasound- images in people with Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate. Read more about this study

Who is it for?: Ages 45 to 75 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: systematic biopsies and Targeted biopsies guided by a fusion of MRI and ultrasound- images
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 6 sitesFrance
Study dates: Jun 2014to Feb 2015
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 45 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

patient from 45 to 75 years old;
Serum level of PSA > 4,0 ng / mL;
Multiparametric prostate IRM, performed before inclusion and which confirm the diagnosis of suspected target;
No opposition of the patient notified in the medical record
patient member in a national insurance scheme.

Who cannot join

Previous prostate biopsy;
suspicious digital rectal examination;
serum PSA > 20,0 ng / mL;
treatment with 5 alpha reductase inhibitor during the last 3 months;
untreated urinary infection

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

France6 sites

CHU Grenoble
Grenoble, 38043
Chu Edouard Herriot
Lyon, 69437
CHU Pitié salpêtrière
Paris, 75013
CHU Cochin
Paris, 75014
CHU Toulouse Rangueil
Toulouse, 31076
Clinique Pasteur
Toulouse, 31076

Other trials in France

About this study

Official title: Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.

Read the detailed description

The act of current practice evaluated by this research is the act of prostate biopsies : the patient will have to undergo 12 systematized transrectal echography guided biopsies of the prostate and 3 additional biopsies targeted on the suspicious lesion detected with MRI, which are both done in current practice.

A first operator is not informed of the location of the target. He will perform a series of 12 systematic transrectal ultrasound-guided biopsies of the prostate.
Immediately after the second operator will perform 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Act added by the research: Using a fusion of MRI - ultrasound images software system (Koelis ®).

Conditions: Prostate Cancer
Being tested: systematic biopsies, Targeted biopsies guided by a fusion of MRI and ultrasound- images
Keywords: cancer, prostate, PSA, biopsies, ultrasound, MRI, fusion of images
Medical subject headings: Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

systematic biopsiesProcedure or surgery
Also called Ultrasound-guided biopsies of the prostate
90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
Targeted biopsies guided by a fusion of MRI and ultrasound- imagesProcedure or surgery
Also called Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® system
Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Study groups in NCT02050542
Study group	Role	What they receive
Targeted biopsies guided by a fusion of MRI and ultrasound	Other	After the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system Receives: Procedure: systematic biopsies; Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images
Systematic biopsies	Other	The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate Receives: Procedure: systematic biopsies; Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images

What is being measured

The primary outcome is the main question the study is designed to answer.

Carcinomatous invasion on biopsies samples
The presence of carcinomatous invasion on biopsies samples
Measured: Day 15

Secondary outcomes (3)

Tissue length of biopsy invaded by the detected cancer
Maximal tissue length of biopsy invaded by the detected cancer
Measured: Day 15
Biopsy Gleason score of the detected cancer
Maximal biopsy Gleason score of the detected cancer
Measured: Day 15
Respective duration of each biopsy protocol
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Feb 2015

First posted30 Jan 2014 (estimated)
Study startJun 2014
Primary completionJan 2015
Study completionFeb 2015

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.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
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: Health services research
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02050542
Sponsor's protocol ID: 2013-A00514-41
Other IDs: SC 3065
Acronym: MURIELLE
Status last verified: Nov 2025
First submitted: 29 Jan 2014
Last updated: 20 Nov 2025
Results posted: No
Data monitoring committee: No

Publications

Delongchamps NB, Portalez D, Bruguiere E, Rouviere O, Malavaud B, Mozer P, Fiard G, Cornud F; MURIELLE Study Group. Are Magnetic Resonance Imaging-Transrectal Ultrasound Guided Targeted Biopsies Noninferior to Transrectal Ultrasound Guided Systematic Biopsies for the Detection of Prostate Cancer? J Urol. 2016 Oct;196(4):1069-75. doi: 10.1016/j.juro.2016.04.003. Epub 2016 Apr 12.
PubMed 27079582

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.
ClinicalTrials.gov ID: NCT02050542
Acronym / sponsor ID: MURIELLE / 2013-A00514-41
Conditions: Prostate Cancer
Keywords: cancer, prostate, PSA, biopsies, ultrasound, MRI, fusion of images
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Collaborators: URC-CIC Paris Descartes Necker Cochin
Study start: Jun 2014
Primary completion: Jan 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 30 Jan 2014 (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.

Detailed description

A first operator is not informed of the location of the target. He will perform a series of 12 systematic transrectal ultrasound-guided biopsies of the prostate.
Immediately after the second operator will perform 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system

Act added by the research: Using a fusion of MRI - ultrasound images software system (Koelis ®).

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Targeted biopsies guided by a fusion of MRI and ultrasound	Other	Procedure: systematic biopsies, Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- imagesAfter the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system
Systematic biopsies	Other	Procedure: systematic biopsies, Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- imagesThe patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate

Who may qualify

Ages: 45 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

patient from 45 to 75 years old;
Serum level of PSA > 4,0 ng / mL;
Multiparametric prostate IRM, performed before inclusion and which confirm the diagnosis of suspected target;
No opposition of the patient notified in the medical record
patient member in a national insurance scheme.

Key exclusion criteria (5 listed)

Previous prostate biopsy;
suspicious digital rectal examination;
serum PSA > 20,0 ng / mL;
treatment with 5 alpha reductase inhibitor during the last 3 months;
untreated urinary infection

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
systematic biopsiesAlso: Ultrasound-guided biopsies of the prostate90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate	Procedure or surgery	Systematic biopsies, Targeted biopsies guided by a fusion of MRI and ultrasound
Targeted biopsies guided by a fusion of MRI and ultrasound- imagesAlso: Biopsies of the prostate by fusion of MRI and ultrasound- images with the Koelis ® systemImmediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system	Procedure or surgery	Systematic biopsies, Targeted biopsies guided by a fusion of MRI and ultrasound

Primary outcome

Carcinomatous invasion on biopsies samples
Time frame: Day 15
The presence of carcinomatous invasion on biopsies samples

3 secondary outcomes

Tissue length of biopsy invaded by the detected cancer
Time frame: Day 15
Biopsy Gleason score of the detected cancer
Time frame: Day 15
Respective duration of each biopsy protocol
Time frame: Day 0

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
Results publication: PubMed 27079582Delongchamps NB, Portalez D, Bruguiere E, Rouviere O, Malavaud B, Mozer P, Fiard G, Cornud F; MURIELLE Study Group. Are Magnetic Resonance Imaging-Transrectal Ultrasound Guided Targeted Biopsies Noninferior to Transrectal Ultrasound Guided Systematic Biopsies for the Detection of Prostate Cancer? J Urol. 2016 Oct;196(4):1069-75. doi: 10.1016/j.juro.2016.04.003. Epub 2016 Apr 12.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

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.

François Cornud, MD, PhD study chair

Assistance Publique - Hôpitaux de Paris

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Carcinomatous invasion on biopsies samples (time frame: Day 15). 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 NCT02050542, 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 20 Nov 2025.