Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06024772 | Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer | PHASE3 | NOT YET_RECRUITING | 300 | — | — | Mar 15, 2026 | Feb 1, 2027 | Dec 22, 2025 | 2 | United States, Netherlands |
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...