Clinical trial NCT00911027: SonoVue Guided Prostate Biopsy
Official title: A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Biopsy
Guided
Contrast
Enhanced
SonoVue
Suspicion of prostate cancer
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Bracco Imaging S.p.A.
First posted: 2009-06-01
Enrollment: 282
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male patient, age ≥ 40 years old
* Optimization part only: Diagnosis of prostate cancer
* Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
* Written Informed Consent and willing to comply with protocol requirements

Exclusion Criteria:

* Documented acute prostatitis or urinary tract infections
* Known allergy to sulphur hexafluoride micro bubbles
* Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
* evolving or ongoing myocardial infarction
* typical angina at rest within the previous 7 days
* significant worsening of cardiac symptoms within the previous 7 days
* recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)
* acute cardiac failure, class III/IV cardiac failure
* severe cardiac rhythm disorders
* right-to-left shunts
* Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
* Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)
* Determined by the Investigator that the patient is clinically unsuitable for the study
* Participation in a concurrent clinical trial or in another trial within the past 30 days
* Repeated participation in this trial (the patient should not be enrolled twice in the present study)

Primary outcomes:
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.
timeFrame: Day 1
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Leuven
country: Belgium
facility: University Hospital K.U. Leuven
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Tours
country: France
facility: CHRU Tours - Hôpital Bretonneau
city: Berlin
country: Germany
facility: Institut für Radiologie der Charité
city: Hamburg
country: Germany
facility: Martini-Klinik, Prostate Cancer Center
city: Munich
country: Germany
facility: Urologische Klinik und Poliklinik
city: Bologna
country: Italy
facility: Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"
city: Como
country: Italy
facility: Ospedale Valduce
city: Milan
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: I.R.C.C.S. San Raffaele
city: Palermo
country: Italy
facility: University of Palermo
city: Trieste
country: Italy
facility: University of Trieste
city: Amsterdam
country: Netherlands
facility: AMC University Amsterdam
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: London
country: United Kingdom
facility: Imperial College NHS Trust - Charing Cross
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Maria L Storto, MD
role: STUDY_CHAIR
References: