NCT06024772Not yet recruitingPhase 3
Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer
Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 18 Aug 2023
- Start date
- Oct 2026
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Prostate cancer
- NCT number
- NCT06024772
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From Oct 2026 to the primary completion date, 1 Aug 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant in a clinical trial involving an investigational drug within the past 30 days
- Previous treatment for prostate cancer, including hormone therapy
Other illness
- Patients with known or suspected hypersensitivity to perflutren, polyethylene glycol (PEG), or any other component of Definity
Other
- Clinically unstable, severely ill, or moribund as per treating physician
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam Medical Center Coordinator of this site? Confirm its status | Amsterdam-Zuidoost | Netherlands | Unknown status |
| Sidney Kimmel Cancer Center at Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.