SonoVue Guided Prostate Biopsy

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00911027
• Other study ID #: BR1-127
• Status: Terminated
• Phase: Phase 3
• First received: May 7, 2009
• Last updated: April 24, 2012
• Start date: February 2009
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 282
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Contrast-enhanced ultrasound guided biopsy
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

Procedure:
• ultrasound guided systematic biopsy
Current practice of ultrasound guided systematic biopsy

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck
Belgium	University Hospital K.U. Leuven	Leuven
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Necker-Enfants Malades	Paris
France	CHRU Tours - Hôpital Bretonneau	Tours
Germany	Institut für Radiologie der Charité	Berlin
Germany	Martini-Klinik, Prostate Cancer Center	Hamburg
Germany	Urologische Klinik und Poliklinik	Munich
Italy	Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"	Bologna
Italy	Ospedale Valduce	Como
Italy	European Institute of Oncology	Milan
Italy	I.R.C.C.S. San Raffaele	Milan
Italy	University of Palermo	Palermo
Italy	University of Trieste	Trieste
Netherlands	AMC University Amsterdam	Amsterdam
Netherlands	Erasmus MC	Rotterdam
United Kingdom	Imperial College NHS Trust - Charing Cross	London

Sponsors (2)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc	Bracco Imaging S.p.A.

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Day 1	No
Secondary	Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy		Day 1	No
Secondary	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.		Day 1	No
Secondary	Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.		Day 1	No