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

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.

Study Overview

• Status: Unknown
• Conditions: Prostatic Neoplasms; Prostate Cancer
• Intervention / Treatment: Other: CEUS and targeted biopsies; Other: MRI and targeted biopsies

• Study Type: Interventional
• Enrollment (Anticipated): 299
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hessel H. Wijkstra, Prof dr ir; Phone Number: +31 20 5666379; Email: h.wijkstra@amc.uva.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Recruiting
    • AMC University Hospital
    • Contact: H. Wijkstra, Prof.Dr.Ir.; Phone Number: +31 20 5666379; Email: h.wijkstra@amc.uva.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies	2 weeks
per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies	2 weeks
per-patient (significant) prostate cancer detection rate of systematic biopsies	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate	2 weeks

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Hessel H. Wijkstra, Prof dr ir, AMC University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: MRI; Prostate Cancer; Contrast Ultrasound; CEUS; Fusion; targeted biopsy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: METC 2015_263