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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02831920
First received: July 5, 2016
Last updated: July 11, 2016
Last verified: July 2016
  Purpose

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 Intervention Phase
Prostate Cancer Prostatic Neoplasms Other: CEUS and targeted biopsies Other: MRI and targeted biopsies Phase 2 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate [ Time Frame: 2 weeks ]

Estimated Enrollment: 299
Study Start Date: December 2015
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • signed informed consent
  • referred for mpMRI and primary biopsy

Exclusion Criteria:

  • Documented acute prostatitis or urinary tract infections
  • History of any clinically evidence of cardiac right-to-left shunts
  • Receives treatment that includes dobutamine
  • Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
  • Has received a biopsy procedure within 30 days before admission into this study
  • Has received a biopsy procedure at the Academic Medical Center within a year before admission into this study
  • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
  • Is incapable of understanding the language in which the information for the patient is given
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02831920

Locations
Netherlands
AMC University Hospital Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: H. Wijkstra, Prof.Dr.Ir.    +31 20 5666379    h.wijkstra@amc.uva.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Responsible Party: Prof. dr. ir. H. Wijkstra, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02831920     History of Changes
Other Study ID Numbers: METC 2015_263
Study First Received: July 5, 2016
Last Updated: July 11, 2016

Keywords provided by Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Prostate Cancer
MRI
CEUS
Contrast Ultrasound
Fusion
targeted biopsy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 23, 2017