Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004117

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004117
  •   2012/10/09
  •   2009/05/07
  •   no
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Secondary IDs

  •   NCT00911027  (ClinicalTrials.gov)
  •   BR1-127  (Bracco Diagnostics, Inc)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Contrast-enhanced ultrasound guided biopsy
  •   Procedure: ultrasound guided systematic biopsy
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Crossover
  •   III
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Primary Outcome

- 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

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Secondary Outcome

- 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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Countries of Recruitment

  •   Austria
  •   Belgium
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2009/02/27
  •   282
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   40   Years
  •   no maximum age
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Additional 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

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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)

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Addresses

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    • Bracco Diagnostics, Inc
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    • Bracco Imaging S.p.A.
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    •   [---]*
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    • Bracco Diagnostics, Inc
    • Maria L Storto, MD 
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    • Bracco Diagnostics, Inc
    • Maria L Storto, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2011/03/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.