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

Not Applicable

• Conditions: Prostate Cancer; Prostatic Neoplasms
• Interventions: Other: CEUS and targeted biopsies; Other: MRI and targeted biopsies

• Registration Number: NCT02831920
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-07
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 299

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	MRI and targeted biopsies	every patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control.
Single Arm	CEUS and targeted biopsies	every patient undergoes mpMRI and targeted biopsies, CEUS and targeted biopsies and systematic biopsies. Every patient is therefore its own control.

Primary Outcome Measures

Name	Time	Method
per-patient (significant) prostate cancer detection rate of systematic biopsies	2 weeks
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AMC University Hospital; 🇳🇱 Amsterdam, Netherlands