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 - SonoVue guided prostate biopsy
- Conditions
- Patients with suspected prostate cancer (For the optimization part: patients with a diagnosis of prostate cancer).MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer
- Registration Number
- EUCTR2007-007666-38-DE
- Lead Sponsor
- Bracco Imaging SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 602
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 <= 10 ng/mL
OR
Patient who has already been submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
•Provides written Informed Consent and is willing to comply with protocol requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method