E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Suspected prostate cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006890 |
E.1.2 | Term | Ca prostate |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 who are 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. |
|
E.2.2 | Secondary objectives of the trial |
-Secondary objectives 1: evaluation of the rate of patients negative to the systematic biopsy among the population that will not receive the targeted biopsy. -Secondary objectives 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 objectives 3: evaluation of the Gleason Score of bioptic samples and its relationship with the contrast enhanced signal assessment scores. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 ≤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 |
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E.4 | Principal exclusion criteria |
For both the first optimization part and the main part of the study, exclude a patient from this study if the patient does not fulfill the inclusion criteria, or 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 |
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E.5 End points |
E.5.1 | 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 who are candidates to a bioptic procedure |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
altra procedura diagnostica |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |