SonoVue Guided Prostate Biopsy

This study has been terminated.
(Failure to meet primary objective)
Sponsor:
Collaborator:
Bracco Imaging SpA
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00911027
First received: May 7, 2009
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Contrast-enhanced ultrasound guided biopsy
Procedure: ultrasound guided systematic biopsy
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SonoVue guided biopsy 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

Other Name: SonoVue guided biopsy
Systematic biopsy Procedure: ultrasound guided systematic biopsy
Current practice of ultrasound guided systematic biopsy

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911027

Locations
Austria
Medical University Innsbruck
Innsbruck, Austria, 6020
Belgium
University Hospital K.U. Leuven
Leuven, Belgium, 3000
France
Hôpital Edouard Herriot
Lyon, France, 69437
Hôpital Necker-Enfants Malades
Paris, France, 75743
CHRU Tours - Hôpital Bretonneau
Tours, France, 37044
Germany
Institut für Radiologie der Charité
Berlin, Germany, 10117
Martini-Klinik, Prostate Cancer Center
Hamburg, Germany, 20246
Urologische Klinik und Poliklinik
Munich, Germany, 81377
Italy
Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi"
Bologna, Italy, 40138
Ospedale Valduce
Como, Italy, 22100
I.R.C.C.S. San Raffaele
Milan, Italy, 20132
European Institute of Oncology
Milan, Italy, 20100
University of Palermo
Palermo, Italy, 90127
University of Trieste
Trieste, Italy, 34149
Netherlands
AMC University Amsterdam
Amsterdam, Netherlands, 1100 DD
Erasmus MC
Rotterdam, Netherlands, 3015 CE
United Kingdom
Imperial College NHS Trust - Charing Cross
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Bracco Diagnostics, Inc
Bracco Imaging SpA
Investigators
Study Chair: Maria L Storto, MD Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00911027     History of Changes
Other Study ID Numbers: BR1-127
Study First Received: May 7, 2009
Last Updated: April 24, 2012
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bracco Diagnostics, Inc:
Prostate
Cancer
Biopsy
Guided
Contrast
Enhanced
SonoVue
Suspicion of prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014