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

Primary Purpose

Prostate Cancer, Prostatic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CEUS and targeted biopsies
MRI and targeted biopsies
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, MRI, CEUS, Contrast Ultrasound, Fusion, targeted biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • AMC University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

every patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control.

Outcomes

Primary Outcome Measures

per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies
per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies
per-patient (significant) prostate cancer detection rate of systematic biopsies

Secondary Outcome Measures

complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate

Full Information

First Posted
July 5, 2016
Last Updated
January 16, 2019
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT02831920
Brief Title
CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer
Official Title
CEUS Targeted Biopsies Compared to mpMRI Targeted and Systematic Biopsies for the Detection of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Neoplasms
Keywords
Prostate Cancer, MRI, CEUS, Contrast Ultrasound, Fusion, targeted biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
299 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
every patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control.
Intervention Type
Other
Intervention Name(s)
CEUS and targeted biopsies
Intervention Type
Other
Intervention Name(s)
MRI and targeted biopsies
Primary Outcome Measure Information:
Title
per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies
Time Frame
2 weeks
Title
per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies
Time Frame
2 weeks
Title
per-patient (significant) prostate cancer detection rate of systematic biopsies
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate
Time Frame
2 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hessel H. Wijkstra, Prof dr ir
Phone
+31 20 5666379
Email
h.wijkstra@amc.uva.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hessel H. Wijkstra, Prof dr ir
Organizational Affiliation
AMC University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMC University Hospital
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Wijkstra, Prof.Dr.Ir.
Phone
+31 20 5666379
Email
h.wijkstra@amc.uva.nl

12. IPD Sharing Statement

Citations:
PubMed Identifier
28381220
Citation
Postema AW, Scheltema MJ, Mannaerts CK, Van Sloun RJ, Idzenga T, Mischi M, Engelbrecht MR, De la Rosette JJ, Wijkstra H. The prostate cancer detection rates of CEUS-targeted versus MRI-targeted versus systematic TRUS-guided biopsies in biopsy-naive men: a prospective, comparative clinical trial using the same patients. BMC Urol. 2017 Apr 5;17(1):27. doi: 10.1186/s12894-017-0213-7.
Results Reference
derived

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

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