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

NCT ID: NCT02831920

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-07
• Study Completion Date: 2019-12-31

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.

Conditions

Prostate Cancer; Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single Arm

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

Group Type: EXPERIMENTAL

CEUS and targeted biopsies

Intervention Type: OTHER

MRI and targeted biopsies

Intervention Type: OTHER

Interventions

CEUS and targeted biopsies

Intervention Type: OTHER

MRI and targeted biopsies

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. ir. H. Wijkstra

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hessel H. Wijkstra, Prof dr ir

Role: PRINCIPAL_INVESTIGATOR

AMC University Hospital

Locations

AMC University Hospital

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Hessel H. Wijkstra, Prof dr ir

Role: CONTACT

h.wijkstra@amc.uva.nl

+31 20 5666379

Facility Contacts

H. Wijkstra, Prof.Dr.Ir.

Role: primary

h.wijkstra@amc.uva.nl

+31 20 5666379

References

Butler MB, Papageorgiou G, Kanoulas ED, Voulgaridou V, Wijkstra H, Mischi M, Mannaerts CK, McDougall S, Duncan WC, Lu W, Sboros V. Mapping of prostate cancer microvascular patterns using super-resolution ultrasound imaging. Eur Radiol Exp. 2025 Feb 20;9(1):25. doi: 10.1186/s41747-025-00561-6.

Reference Type: DERIVED

PMID: 39976631 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28381220 (View on PubMed)

Other Identifiers

METC 2015_263

Identifier Type: -

Identifier Source: org_study_id