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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02831920
• Other study ID #: METC 2015_263
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Hessel H. Wijkstra, Prof dr ir
• Phone: +31 20 5666379
• Email: h.wijkstra[@]amc.uva.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 299
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• CEUS and targeted biopsies

• MRI and targeted biopsies

Locations

Country	Name	City	State
Netherlands	AMC University Hospital	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	per-patient (significant) prostate cancer detection rate of mpMRI targeted biopsies		2 weeks
Primary	per-patient (significant) prostate cancer detection rate of CEUS targeted biopsies		2 weeks
Primary	per-patient (significant) prostate cancer detection rate of systematic biopsies		2 weeks
Secondary	complementarity of CEUS and mpMRI targeted biopsies in terms of per-patient (significant) cancer detection rate		2 weeks