Prostate CancerMRI-FIRST01NCT02485379
Assessment of Prostate MRI Before Prostate Biopsies
A study testing Prostate biopsy in people with Prostate Cancer, run by Hospices Civils de Lyon at 20 sites in France.
Trial summary
Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific Antigen (PSA) level, it is currently recommended to perform "blinded" systematically distributed biopsies with 10-18 samples obtained… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 20 sitesFrance
- Study dates
- Jul 2015to Nov 2016
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient referred for prostate mp-MRI before a first set of prostate biopsies, with a planned time interval of less than 3 months between MRI and biopsies
- Age ≤75 years
- PSA level ≤20 ng/mL
- Clinical stage ≤T2c
- Patient insured under the French social security system or beneficiary of an equivalent regime
Who cannot join
- Contraindication to transrectal biopsy
- Contraindication to MRI
- History of hip prosthesis
- History of androgen deprivation therapy
- Patients with history of prostate cancer diagnosed on TURP
- Patients with history of pelvic radiation therapy (whatever the reason)
- Patient deprived of freedom following a court or administrative order
- Patient under guardianship or under legal guardianship
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Groupe Hospitalier Pellegrin - CHU de Bordeaux
Bordeaux, 33076
Hôpital Michallon - CHU de Grenoble
Grenoble, 38043
Hôpital Huriez - CHU de Lille
Lille, 59037
Hôpital Privé La Louvière
Lille, 59042
CLIMAL (Centre Libéral Imagerie Médicale Agglomération Lille)
Lille, 59700
Centre Hospitalier St Joseph St Luc
Lyon, 69365
Hôpital Edouard Herriot
Lyon, 69437
Institut Paoli Calmettes
Marseille, 13273
Clinique Jules Verne
Nantes, 44300
Hopital Pitie Salpetriere
Paris, 75013
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Necker
Paris, 75015
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU de Saint-Etienne
Saint-Etienne, 42055
Clinique Urologique Nantes Atlantis
Saint-Herblain, 44815
IRMAS
Saint-Priest-en-Jarez, 42270
Nouvel Hopital Civil - CHU de Strasbourg
Strasbourg, 67091
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - CHU de Toulouse
Toulouse, 31059
CHU Nancy Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Improvement in the Detection of Aggressive Prostate Cancer by Targeted Biopsies Using Multiparametric MRI Findings
Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific Antigen (PSA) level, it is currently recommended to perform "blinded" systematically distributed biopsies with 10-18 samples obtained from predefined locations in the gland.
These so-called systematic biopsies (SB) may lead to improper patient management by (i) missing clinically significant cancer, especially in the anterior half of the gland that tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer foci that may result in overtreatments, (iii) undersampling the tumor foci and thus underestimating their volume and aggressiveness.
Read more
Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the aggressiveness of detected cancers than SB. However, these monocenter studies only provide low-level evidence and three recent independent reviews of literature concluded that there was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared to SB. This is particularly important since many academic and private centers in France already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that this approach becomes the norm without being properly evaluated and it is crucial and urgent to perform a controlled multicentric study to provide high-level evidence as to whether mp-MRI should or should not be obtained before prostate biopsy.
One controlled multicentric study has been published recently in which SB and TB had been obtained by two different operators in 95 patients. TB yielded a significantly higher detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients with negative mp-MRI were not included.
Research hypotheses: There is currently no robust multicenter trial comparing prostate TB based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre prospective trial comparing the results of SB and TB performed in the same patients by two independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a significantly higher percentage of patients than SB.
Main objective: To compare the percentage of patients with "clinically significant cancer" (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.
- Conditions
- Prostate Cancer
- Being tested
- Prostate biopsy
- Keywords
- Prostate cancer, Multiparametric MRI, Prostate biopsy, Targeted biopsy, Comparative study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate biopsyProcedure or surgery
Systematic biopsies (SB) and targeted biopsies (TB) are performed in the same patients by two independent operators. In patients without abnormalities on mp-MRI, no targeted biopsies will be carried out and the detection of "clinically significant cancer" will be considered as negative for the TB strategy.
| Study group | Role | What they receive |
|---|---|---|
| Prostate biopsy | Other | Systematic biopsies (SB) and targeted biopsies (TB) are performed in the same patients by two independent operators. In patients without abnormalities on mp-MRI, no targeted biopsies will be carried out and the detection of "clinically significant cancer" will be considered as negative for the TB strategy. Receives: Procedure: Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of "clinically significant cancer" (using definition A, i.e. Gleason ≥7 cancers) in at least one core of SB or TB.
Measured: Between 1 and 4 months after the enrollment
Secondary outcomes (9)
To compare the percentage of patients with "clinically significant cancer" (using definition B, i.e. any Gleason ≥7 cancer or Gleason 6 cancer with at least one sample with ≥6 mm of cancer) detected by SB and TB.
Measured: Between 1 and 4 months after the enrollment
To compare the percentage of patients with "clinically significant cancer" (using definition C, i.e. any Gleason ≥7 (4+3) cancer)
Measured: Between 1 and 4 months after the enrollment
To compare the percentage of patients with "clinically insignificant cancer" (defined as a Gleason ≤6 cancer with ≤2 positive samples and <3 mm of cancer on the positive samples) detected by SB and TB.
Measured: Between 1 and 4 months after the enrollment
To compare the percentage of patients with Gleason ≥7 cancer detected by SB and TB in different subgroups
The different subgroups are :
- Patients with clinical stage T1c (i.e. normal DRE) versus T2a-T2c,
- Patients with a PSA level <10 ng/mL versus 10-20 ng/mL,
- Patients with a prostate volume ≤50 cc versus >50 cc,
- Patients in whom TB have been performed with ultrasound/MRI fusion versus cognitive guidance
Measured: Between 1 and 4 months after the enrollment
To compare the percentage of patients detected by TB and by SB+TB with "clinically significant cancer" (using definitions A, B and C) and "clinically insignificant" cancer.
Measured: Between 1 and 4 months after the enrollment
To compare the percentage of patients with "clinically significant cancer" (using definitions A, B and C) detected by the 2 optional US-guided biopsies and by the regular 12 systematic biopsies.
Measured: Between 1 and 4 months after the enrollment
To evaluate the percentage of patients with overall cancer and with "clinically significant cancer" (using definitions A, B and C) on SB and who had a negative MRI
Measured: Between 1 and 4 months after the enrollment
To evaluate the percentage of patients with overall cancer and "clinically significant cancer" (using definitions A, B and C) on SB and who had a positive MRI in the sextant(s) that were positive on SB.
Measured: Between 1 and 4 months after the enrollment
To evaluate the percentage of patients with discordant results (Gleason score, maximum length of invasion) between the local pathological analysis and between the central pathological review.
Measured: Between 1 and 4 months after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016
- Study completionNov 2016
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 Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485379
- Sponsor's protocol ID
- 69HCL14_0440
- Acronym
- MRI-FIRST01
- Status last verified
- Jul 2017
- First submitted
- 24 Jun 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Rouviere O, Puech P, Renard-Penna R, Claudon M, Roy C, Mege-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L, Ruffion A, Colombel M, Crouzet S, Schott AM, Lemaitre L, Rabilloud M, Grenier N; MRI-FIRST Investigators. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol. 2019 Jan;20(1):100-109. doi: 10.1016/S1470-2045(18)30569-2. Epub 2018 Nov 21.
PubMed 30470502
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in the Detection of Aggressive Prostate Cancer by Targeted Biopsies Using Multiparametric MRI Findings
- ClinicalTrials.gov ID
- NCT02485379
- Acronym / sponsor ID
- MRI-FIRST01 / 69HCL14_0440
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Multiparametric MRI, Prostate biopsy, Targeted biopsy, Comparative study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 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.
Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific Antigen (PSA) level, it is currently recommended to perform "blinded" systematically distributed biopsies with 10-18 samples obtained from predefined locations in the gland.
These so-called systematic biopsies (SB) may lead to improper patient management by (i) missing clinically significant cancer, especially in the anterior half of the gland that tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer foci that may result in overtreatments, (iii) undersampling the tumor foci and thus underestimating their volume and aggressiveness.
Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the aggressiveness of detected cancers than SB. However, these monocenter studies only provide low-level evidence and three recent independent reviews of literature concluded that there was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared to SB. This is particularly important since many academic and private centers in France already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that this approach becomes the norm without being properly evaluated and it is crucial and urgent to perform a controlled multicentric study to provide high-level evidence as to whether mp-MRI should or should not be obtained before prostate biopsy.
One controlled multicentric study has been published recently in which SB and TB had been obtained by two different operators in 95 patients. TB yielded a significantly higher detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients with negative mp-MRI were not included.
Research hypotheses: There is currently no robust multicenter trial comparing prostate TB based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre prospective trial comparing the results of SB and TB performed in the same patients by two independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a significantly higher percentage of patients than SB.
Main objective: To compare the percentage of patients with "clinically significant cancer" (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate biopsy | Other | Procedure: Prostate biopsySystematic biopsies (SB) and targeted biopsies (TB) are performed in the same patients by two independent operators. In patients without abnormalities on mp-MRI, no targeted biopsies will be carried out and the detection of "clinically significant cancer" will be considered as negative for the TB strategy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient referred for prostate mp-MRI before a first set of prostate biopsies, with a planned time interval of less than 3 months between MRI and biopsies
- Age ≤75 years
- PSA level ≤20 ng/mL
- Clinical stage ≤T2c
- Patient insured under the French social security system or beneficiary of an equivalent regime
Key exclusion criteria (8 listed)
- Contraindication to transrectal biopsy
- Contraindication to MRI
- History of hip prosthesis
- History of androgen deprivation therapy
- Patients with history of prostate cancer diagnosed on TURP
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 |
|---|---|---|
| Prostate biopsySystematic biopsies (SB) and targeted biopsies (TB) are performed in the same patients by two independent operators. In patients without abnormalities on mp-MRI, no targeted biopsies will be carried out and the detection of "clinically significant cancer" will be considered as negative for the TB strategy. | Procedure or surgery | Prostate biopsy |
Primary outcome
Detection of "clinically significant cancer" (using definition A, i.e. Gleason ≥7 cancers) in at least one core of SB or TB.
Time frame: Between 1 and 4 months after the enrollment
9 secondary outcomes
To compare the percentage of patients with "clinically significant cancer" (using definition B, i.e. any Gleason ≥7 cancer or Gleason 6 cancer with at least one sample with ≥6 mm of cancer) detected by SB and TB.
Time frame: Between 1 and 4 months after the enrollment
To compare the percentage of patients with "clinically significant cancer" (using definition C, i.e. any Gleason ≥7 (4+3) cancer)
Time frame: Between 1 and 4 months after the enrollment
To compare the percentage of patients with "clinically insignificant cancer" (defined as a Gleason ≤6 cancer with ≤2 positive samples and <3 mm of cancer on the positive samples) detected by SB and TB.
Time frame: Between 1 and 4 months after the enrollment
To compare the percentage of patients with Gleason ≥7 cancer detected by SB and TB in different subgroups
Time frame: Between 1 and 4 months after the enrollment
To compare the percentage of patients detected by TB and by SB+TB with "clinically significant cancer" (using definitions A, B and C) and "clinically insignificant" cancer.
Time frame: Between 1 and 4 months after the enrollment
To compare the percentage of patients with "clinically significant cancer" (using definitions A, B and C) detected by the 2 optional US-guided biopsies and by the regular 12 systematic biopsies.
Time frame: Between 1 and 4 months after the enrollment
To evaluate the percentage of patients with overall cancer and with "clinically significant cancer" (using definitions A, B and C) on SB and who had a negative MRI
Time frame: Between 1 and 4 months after the enrollment
To evaluate the percentage of patients with overall cancer and "clinically significant cancer" (using definitions A, B and C) on SB and who had a positive MRI in the sextant(s) that were positive on SB.
Time frame: Between 1 and 4 months after the enrollment
To evaluate the percentage of patients with discordant results (Gleason score, maximum length of invasion) between the local pathological analysis and between the central pathological review.
Time frame: Between 1 and 4 months after the enrollment
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 19 Dec 2025.
- Results publication: PubMed 30470502Rouviere O, Puech P, Renard-Penna R, Claudon M, Roy C, Mege-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L, Ruffion A, Colombel M, Crouzet S, Schott AM, Lemaitre L, Rabilloud M, Grenier N; MRI-FIRST Investigators. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol. 2019 Jan;20(1):100-109. doi: 10.1016/S1470-2045(18)30569-2. Epub 2018 Nov 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate biopsy in people with Prostate Cancer, run by Hospices Civils de Lyon at 20 sites 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 5 inclusion and 8 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Detection of "clinically significant cancer" (using definition A, i.e. Gleason ≥7 cancers) in at least one core of SB or TB. (time frame: Between 1 and 4 months after the enrollment). 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 NCT02485379, 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 19 Dec 2025.