Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment prostate biopsy
Sponsor Hospices Civils de Lyon
Start date July 2015
End date March 2017
Trial size 275 participants
Trial identifier NCT02485379, 69HCL14_0440

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 detect aggressive (Gleason ≥7) cancers in a significantly higher percentage of patients than SB.

Main objective: Compare the percentage of patients with "clinically significant cancer" (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(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.
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.

Primary Outcomes

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

Secondary Outcomes

Measure
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 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 and B) and "clinically insignificant" cancer.
time frame: Between 1 and 4 months after the enrollment

Eligibility Criteria

Male participants from 18 years up to 75 years old.

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

Additional Information

Official title Improvement in the Detection of Aggressive Prostate Cancer by Targeted Biopsies Using Multiparametric MRI Findings
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.