BR1-127

• Research type

  Research Study

• Full title

  A phase III study to compare SonoVue® guided biopsy with systemic biopsy in the detection of prostate malignant lesions in patients with suspected prostate cancer

• Sponsor organisation

  Bracco Imaging S.p.A

• Eudract number

  2007-007666-38

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The proposed study is designed as a comparison between two techniques looking for their difference in cancer lesions detection. Primary objective is the 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. The trial will involve 15-20 European centers. The overall study will comprise two sequential parts: the first part aims to the technical optimization of the procedure and the second part corresponds to the main part of the study. During the first part, up to 10patients per center will be enrolled for the technical optimization in order to assure an adequate preparation of all centers. This first part will allow the Investigators to recognize SonoVue©abnormal signal enhancement as a sign of cancer lesion identification. Patients with a diagnosis of prostate cancer will be enrolled in the first part and will receive a SonoVue© injection for lesions identification only. They'll not be submitted to the overall procedure planned in the main part of the study comprising additional SonoVue© injections for guiding a targeted biopsy and will be assessed for safety evaluation only. Afterwards, 452 patients (271candidates for a first bioptic procedure and 181 for the second one) will then be enrolled with a competitive recruitment for the main part of the study and will constitute the efficacy population. The complete study, either for the first optimization part and for the main part, will last maximal 30 hours per patient.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  08/H0706/86

• Date of REC Opinion

  3 Nov 2008

• REC opinion

  Further Information Favourable Opinion