Patients with suspected prostate cancer (For the optimization part: patients with a diagnosis of prostate cancer). MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Trade Name: SonoVue
Product Name: SonoVue®
Product Code: n.a.
Pharmaceutical Form: Injection*
INN or Proposed INN: Sulfur Hexafluoride (SF6)
CAS Number: 002551-62-4
Current Sponsor code: BR1
Other des
Sponsors
Bracco Imaging SPA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: For the first optimization part of the study, enroll a patient if the patient meets the following inclusion criteria: • Male patient, age = 40 years old • Has a diagnosis of prostate cancer • Provides written Informed Consent and is willing to comply with protocol requirements For the main part of the study, enroll a patient if the patient meets the following inclusion criteria • Male patient, age = 40 years old. • Reporting to the urology department of the study centre with suspected prostate cancer scheduled for first biopsy and having tPSA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For both the first optimization part and the main part of the study, exclude a patient if any of the following conditions are observed: • Has documented acute prostatitis or urinary tract infections • Has known allergy to sulphur hexafluoride micro bubbles • Has had 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 • Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome • Has received a bioptic procedure within 30 days before admission into this study (this exclusion criteria should be taken on consideration only for the main part of the study and not for the first optimization part) • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study. • Is determined by the Investigator that the patient is clinically unsuitable for the study. • Is incapable of understanding the language in which the information for the patient is given • 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) • Inclusion of patients dependent on the sponsor or investigator into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determination of the potentiality of SonoVue to guide prostate biopsy increasing the detection rate of malignant lesions of 6% points in absolute terms compared to the detection rate of the conventional systematic biopsy on patients candidates to a bioptic procedure. The study population comprises both candidates to a first bioptic exam and candidates to a second bioptic procedure having had a previous negative result independently from the present study.;Secondary Objective: - Secondary Objective 1: evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy - Secondary Objective 2: assessment of the potentiality of SonoVue guided biopsy to increase the percentage of positive bioptic cores compared to the percentage of positive cores obtained with systematic biopsy, intra-patient in the population of the patients that received both bioptic procedures. - Secondary Objective 3: evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores. ;Primary end point(s): Determination of the potentiality of SonoVue to guide prostate biopsy increasing the detection rate of malignant lesions of 6% points in absolute terms compared to the detection rate of the conventional systematic biopsy on patients candidates to a bioptic procedure. | — |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands
Outcome results
None listed