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

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

Status

Unknown

Conditions

Prostatic Neoplasms

Prostate Cancer

Treatments

Other: MRI and targeted biopsies

Other: CEUS and targeted biopsies

Study type

Interventional

Funder types

Other

Identifiers

NCT02831920

METC 2015_263

Details and patient eligibility

About

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.

Enrollment

299 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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