Study Results
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Basic Information
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COMPLETED
NA
275 participants
INTERVENTIONAL
2015-07-31
2016-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Prostate biopsy
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
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.
Interventions
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Prostate biopsy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
MALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Groupe Hospitalier Pellegrin - CHU de Bordeaux
Bordeaux, , France
Hôpital Michallon - CHU de Grenoble
Grenoble, , France
Hôpital Huriez - CHU de Lille
Lille, , France
Hôpital Privé La Louvière
Lille, , France
CLIMAL (Centre Libéral Imagerie Médicale Agglomération Lille)
Lille, , France
Centre Hospitalier St Joseph St Luc
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Clinique Jules Verne
Nantes, , France
Hopital Pitie Salpetriere
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Necker
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Saint-Etienne
Saint-Etienne, , France
Clinique Urologique Nantes Atlantis
Saint-Herblain, , France
IRMAS
Saint-Priest-en-Jarez, , France
Nouvel Hopital Civil - CHU de Strasbourg
Strasbourg, , France
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole - CHU de Toulouse
Toulouse, , France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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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.
Other Identifiers
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69HCL14_0440
Identifier Type: -
Identifier Source: org_study_id