This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
282
One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part One to four bolus (each 2.4mL) of SonoVue per patient in the main part
Current practice of ultrasound guided systematic biopsy
Medical University Innsbruck
Innsbruck, Austria
University Hospital K.U. Leuven
Leuven, Belgium
Hôpital Edouard Herriot
Determination of potentiality of SonoVue to guide prostate biopsy increasing detection rate of malignant lesions of 6% points (absolute terms) compared to detection rate of conventional systematic biopsy on patients candidates to a bioptic procedure.
Time frame: Day 1
Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy
Time frame: Day 1
Assessment of potentiality of SonoVue guided biopsy to increase % of positive bioptic cores compared to % of positive cores obtained with systematic biopsy, intra-patient in the population of the patients that received both bioptic procedures.
Time frame: Day 1
Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.
Time frame: Day 1
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Lyon, France
Hôpital Necker-Enfants Malades
Paris, France
CHRU Tours - Hôpital Bretonneau
Tours, France
Institut für Radiologie der Charité
Berlin, Germany
Martini-Klinik, Prostate Cancer Center
Hamburg, Germany
Urologische Klinik und Poliklinik
Munich, Germany
Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"
Bologna, Italy
Ospedale Valduce
Como, Italy
...and 7 more locations