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Perflutren lipid microsphere · 1 trial · 1 indication
Will compare PCa detection rate of 3D mp-US combined with systematic biopsy to detection rate of multiparametric magnetic resonance imaging (mp-MRI) combined with systematic biopsy. Will evaluate paired biopsy data for non-inferiority and superiority endpoints, comparing the detection rate of clinically significant PCa with mp-US + systematic biopsy to the detection rate of mp-MRI + systematic biopsy. This analysis will be repeated using both definitions of clinically significant PCa. Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, standard deviation (SD), median, and range.
| Arm | Type | Description |
|---|---|---|
| Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies) | EXPERIMENTAL | Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study. |
| Name | Type | Description |
|---|---|---|
| ultiparametric Magnetic Resonance Imaging | PROCEDURE | Undergo mp-MRI |
| Perflutren lipid microsphere | DRUG | Given IV |
| Transrectal Ultrasound | PROCEDURE | Undergo transrectal mp-US |
| Biopsy of Prostate | PROCEDURE | Undergo prostate biopsies |
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...
Perflutren lipid microsphere is an investigational agent being studied for use in prostate carcinoma. It is currently in Phase 3 clinical development as part of a multiparametric ultrasound approach for the diagnosis of clinically significant prostate cancer. The agent is being evaluated in a single active trial with an estimated enrollment of 300 participants.
Perflutren lipid microsphere is a small molecule modality. The specific molecular target or target class for this agent has not been disclosed in the available information. Its mechanism of action is not detailed, but it is being investigated in the context of multiparametric ultrasound for prostate cancer diagnosis.
Perflutren lipid microsphere is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is conducting a Phase 3 clinical trial for this agent in prostate carcinoma, with the study being run in the United States and the Netherlands.
Perflutren lipid microsphere is currently in Phase 3 clinical development. It is an investigational agent and has not been approved by regulatory authorities. The ongoing Phase 3 trial is designed to evaluate its use in diagnosing clinically significant prostate cancer, with an estimated enrollment of 300 participants.
Perflutren lipid microsphere is being studied in one Phase 3 clinical trial with the identifier NCT06024772. The trial is titled 'Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer' and is not yet recruiting. It is an uncontrolled, non-randomized study enrolling 300 male participants aged 18 years and older with prostate carcinoma.