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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
Sponsor:
Information provided by (Responsible Party):
Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.


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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies [ Time Frame: 2 weeks ]
  2. per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies [ Time Frame: 2 weeks ]
  3. per-patient (significant) prostate cancer detection rate of systematic biopsies [ Time Frame: 2 weeks ]

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


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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

Information from the National Library of Medicine

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


Contacts
Contact: Hessel H. Wijkstra, Prof dr ir +31 20 5666379 h.wijkstra@amc.uva.nl

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)
Investigators
Principal Investigator: Hessel H. Wijkstra, Prof dr ir AMC University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

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