Assessment of Prostate MRI Before Prostate Biopsies

Prostate Cancer Clinical Trial

— MRI-FIRST01  

Official title:

Improvement in the Detection of Aggressive Prostate Cancer by Targeted Biopsies Using Multiparametric MRI Findings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485379
• Other study ID #: 69HCL14_0440
• Status: Completed
• Phase: N/A
• First received: June 24, 2015
• Last updated: July 20, 2017
• Start date: July 2015
• Est. completion date: November 2016

Study information

• Verified date: July 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Pellegrin - CHU de Bordeaux	Bordeaux
France	Hôpital Michallon - CHU de Grenoble	Grenoble
France	CLIMAL (Centre Libéral Imagerie Médicale Agglomération Lille)	Lille
France	Hôpital Huriez - CHU de Lille	Lille
France	Hôpital Privé La Louvière	Lille
France	Centre Hospitalier St Joseph St Luc	Lyon
France	Hôpital Edouard Herriot	Lyon Cedex 03
France	Institut Paoli Calmettes	Marseille
France	Clinique Jules Verne	Nantes
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Necker	Paris
France	Hopital Pitie Salpetriere	Paris
France	Centre Hospitalier Lyon Sud	Pierre Bénite
France	CHU de Saint-Etienne	Saint-Etienne
France	IRMAS	Saint-Priest-en-Jarez
France	Clinique Urologique Nantes Atlantis	St Herblain
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	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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	Between 1 and 4 months after the enrollment
Secondary	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
Secondary	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.		Between 1 and 4 months after the enrollment
Secondary	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		Between 1 and 4 months after the enrollment
Secondary	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.		Between 1 and 4 months after the enrollment
Secondary	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.		Between 1 and 4 months after the enrollment