Clinical trial · Interventional
Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer
Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase III trial compares the use of contrast-enhanced multiparametric ultrasound (mp-US) to multiparametric magnetic resonance imaging (mp-MRI) for the diagnosis of clinically significant prostate cancer (PCa). A mp-US is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Perflutren lipid michrosphere (Definity) is a contrast agent that uses microbubbles to enhance ultrasound images of the prostate. Doctors hope to learn if the Definity-enhanced mp-US imaging technique can accurately direct targeted biopsy for the detection of clinically significant prostate cancer when compared to standard of care mp-MRI.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy of Prostate | Procedure | — | UNRESOLVED |
| Perflutren lipid microsphere | Drug | — | UNRESOLVED |
| Transrectal Ultrasound | Procedure | — | UNRESOLVED |
| ultiparametric Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies)
- description
- Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.
- interventionNames
- Procedure: ultiparametric Magnetic Resonance Imaging
- Drug: Perflutren lipid microsphere
- Procedure: Transrectal Ultrasound
- Procedure: Biopsy of Prostate
Primary outcomes (1)
- measure
- Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy
- timeFrame
- Up to 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available