NCT02485379

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 19, 2025

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

June 24, 2015

Last Update Submit

December 13, 2025

Conditions

Prostate Cancer

Keywords

Prostate cancerMultiparametric MRIProstate biopsyTargeted biopsyComparative study

Outcome Measures

Primary Outcomes (1)

  • Detection of "clinically significant cancer" (using definition A, i.e. Gleason ≥7 cancers) in at least one core of SB or TB.

    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.

    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)

    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.

    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

    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.

    Between 1 and 4 months after the enrollment

  • +4 more secondary outcomes

Study Arms (1)

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.

Procedure: Prostate biopsy

Interventions

Prostate biopsyPROCEDURE

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.

Prostate biopsy

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Groupe Hospitalier Pellegrin - CHU de Bordeaux

Bordeaux, 33076, France

Location

Hôpital Michallon - CHU de Grenoble

Grenoble, 38043, France

Location

Hôpital Huriez - CHU de Lille

Lille, 59037, France

Location

Hôpital Privé La Louvière

Lille, 59042, France

Location

CLIMAL (Centre Libéral Imagerie Médicale Agglomération Lille)

Lille, 59700, France

Location

Centre Hospitalier St Joseph St Luc

Lyon, 69365, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Clinique Jules Verne

Nantes, 44300, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Necker

Paris, 75015, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Clinique Urologique Nantes Atlantis

Saint-Herblain, 44815, France

Location

IRMAS

Saint-Priest-en-Jarez, 42270, France

Location

Nouvel Hopital Civil - CHU de Strasbourg

Strasbourg, 67091, France

Location

Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - CHU de Toulouse

Toulouse, 31059, France

Location

CHU Nancy Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • 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.

    PMID: 30470502RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

June 30, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 19, 2025

Record last verified: 2017-07

Locations

FR(20)