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CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer

NCT02831920 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2019-01-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

CEUS and targeted biopsies

OTHER

MRI and targeted biopsies

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Hessel H. Wijkstra, Prof dr ir · AMC University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-07
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02831920 on ClinicalTrials.gov