Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer

PRIMARY OBJECTIVE:

I. To demonstrate non-inferiority between the detection rate of clinically significant PCa with 3-dimensional (3D) mp-US + systematic biopsy compared to the detection rate of mp-MRI + systematic biopsy.

II. To compare the positive yield of targeted biopsy cores based on mp-US + systematic biopsy with targeted biopsy based on mp-MRI + systematic biopsy, for detection of clinically significant PCa.

SECONDARY OBJECTIVES:

I. To demonstrate non-inferiority of a biopsy approach utilizing targeted biopsy cores based on mp-US compared with targeted biopsy based on mp-MRI, for detection of clinically significant PCa.

II. To construct an optimal logistic regression model to predict the presence of clinically significant PCa based on the mp-US elements as well as the prostate specific antigen (PSA), PSA velocity and any other biological variables (e.g., age).

OUTLINE:

Patients undergo mp-MRI, receive Definity intravenously (IV), and undergo transrectal mp-US and prostate biopsies on study.

Inclusion criteria

• Subject must be scheduled for a prostate biopsy, based on an elevated PSA (> 3.0ng/ml) per most recent National Comprehensive Cancer Network (NCCN) guidelines, elevated PSA velocity (> 0.75ng/ml/year), or abnormal digital rectal examination
• Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate including the additional study biopsies
• Subject must be a male at least 18 years of age when informed consent is obtained

Exclusion criteria

• Participant in a clinical trial involving an investigational drug within the past 30 days
• Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol (PEG), or any other component of Definity
• Previous treatment for prostate cancer, including hormone therapy
• Clinically unstable, severely ill, or moribund as per treating physician