SonoVue Guided Prostate Biopsy

NCT00911027 | Terminated Phase 3

• 1 other identifier: BR1-127
• Study Type: interventional
• Target: 282
• Locations: 7 countries
• Sites: 17

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.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Biopsy; Guided; Contrast; Enhanced; SonoVue; Suspicion of prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy

  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.

  Day 1

• Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores.

  Day 1

Study Arms (2)

SonoVue guided biopsy

EXPERIMENTAL

Drug: Contrast-enhanced ultrasound guided biopsy

Systematic biopsy

OTHER

Procedure: ultrasound guided systematic biopsy

Interventions

Contrast-enhanced ultrasound guided biopsy DRUG

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

Also known as: SonoVue guided biopsy

SonoVue guided biopsy

ultrasound guided systematic biopsy PROCEDURE

Current practice of ultrasound guided systematic biopsy

Systematic biopsy

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead
• Bracco Imaging S.p.A.: collaborator

Study Sites (17)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

University Hospital K.U. Leuven

Leuven, 3000, Belgium

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hôpital Necker-Enfants Malades

Paris, 75743, France

Location

CHRU Tours - Hôpital Bretonneau

Tours, 37044, France

Location

Institut für Radiologie der Charité

Berlin, 10117, Germany

Location

Martini-Klinik, Prostate Cancer Center

Hamburg, 20246, Germany

Location

Urologische Klinik und Poliklinik

Munich, 81377, Germany

Location

Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"

Bologna, 40138, Italy

Location

Ospedale Valduce

Como, 22100, Italy

Location

European Institute of Oncology

Milan, 20100, Italy

Location

I.R.C.C.S. San Raffaele

Milan, 20132, Italy

Location

University of Palermo

Palermo, 90127, Italy

Location

University of Trieste

Trieste, 34149, Italy

Location

AMC University Amsterdam

Amsterdam, 1100 DD, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Imperial College NHS Trust - Charing Cross

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Maria L Storto, MD

  Bracco Diagnostics, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: June 1, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

IT (6); GB (1); FR (3); NL (2); AU (1); DE (3); BE (1)