CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer
The current standard for Prostate Cancer (PCa) detection remains taking 10-12 systematic biopsies of the prostate. This approach leads to overdiagnosis of insignificant PCa on the one hand and underdiagnosis and undergrading of significant PCa on the other. multiparametric Magnetic Resonance Imaging (mpMRI) has seen an increasing uptake in the clinics for biopsy targeting, but the value in biopsy naive patients remains controversial. With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. To overcome these difficulties CEUS quantification techniques have been used with encouraging first results. These imaging techniques have been proposed to improve the yield of prostate biopsies and possibly replacing systematic biopsies.
In this trial mpMRI imaging and CEUS + quantification are performed before primary biopsy. Using a fusion device, targeted biopsies are taken from predefined MRI lesions and CEUS lesions, together with standard systematic biopsies in the same patients by separate blinded clinicians. The main outcome measure is the per-patient (significant) prostate cancer detection rate for each of the biopsy regimens.
|Prostate Cancer Prostatic Neoplasms||Other: CEUS and targeted biopsies Other: MRI and targeted biopsies||Phase 2 Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer|
- per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies [ Time Frame: 2 weeks ]
- per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies [ Time Frame: 2 weeks ]
- per-patient (significant) prostate cancer detection rate of systematic biopsies [ Time Frame: 2 weeks ]
- complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate [ Time Frame: 2 weeks ]
|Study Start Date:||December 2015|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
every patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control.
|Other: CEUS and targeted biopsies Other: MRI and targeted biopsies|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02831920
|AMC University Hospital||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: H. Wijkstra, Prof.Dr.Ir. +31 20 5666379 email@example.com|