CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02831920|
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : September 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostatic Neoplasms||Other: CEUS and targeted biopsies Other: MRI and targeted biopsies||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||299 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer|
|Actual Study Start Date :||December 7, 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831920
|Contact: Hessel H. Wijkstra, Prof dr ir||+31 20 email@example.com|
|AMC University Hospital||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: H. Wijkstra, Prof.Dr.Ir. +31 20 5666379 firstname.lastname@example.org|
|Principal Investigator:||Hessel H. Wijkstra, Prof dr ir||AMC University Hospital|