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

NCT02831920 | Unknown

• 1 other identifier: METC 2015_263
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate Cancer; MRI; CEUS; Contrast Ultrasound; Fusion; targeted biopsy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  2 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

CEUS and targeted biopsies OTHER

Single Arm

MRI and targeted biopsies OTHER

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• signed informed consent
• referred for mpMRI and primary biopsy

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

AMC University Hospital

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 39976631 DERIVED

• 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.

  PMID: 28381220 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Hessel H. Wijkstra, Prof dr ir

  AMC University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hessel H. Wijkstra, Prof dr ir

CONTACT

+31 20 5666379; h.wijkstra@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 13, 2016
• Study Start: December 7, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 17, 2019

Record last verified: 2019-01

Locations

NL (1)