Prostate CarcinomaPhase 3NCT06024772
Multiparametric Ultrasound for the Diagnosis of Clinically Significant Prostate Cancer
A Phase 3 study testing ultiparametric Magnetic Resonance Imaging, Perflutren lipid microsphere and Transrectal Ultrasound in people with Prostate Carcinoma, run by Thomas Jefferson University at 2 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- ultiparametric Magnetic Resonance Imaging, Perflutren lipid microsphere and Transrectal Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2026to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Flemming Forsberg, PhD, 215-955-4870, Flemming.Forsberg@jefferson.edu
Netherlands1 site
Amsterdam Medical Center
Amsterdam-Zuidoost
Harrie Beerlage, MD, (020) 4440272, h.p.beerlage@amsterdamumc.nl
About this study
Official title: Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- ultiparametric Magnetic Resonance Imaging, Perflutren lipid microsphere, Transrectal Ultrasound, Biopsy of Prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultiparametric Magnetic Resonance ImagingProcedure or surgery
Also called MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI
Undergo mp-MRI
Perflutren lipid microsphereDrug
Also called Definity
Given IV
Transrectal UltrasoundProcedure or surgery
Also called endorectal ultrasound, ERUS, TRUS
Undergo transrectal mp-US
Biopsy of ProstateProcedure or surgery
Also called Prostate Biopsy, Prostatic Biopsy
Undergo prostate biopsies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ultiparametric Magnetic Resonance Imaging; Drug: Perflutren lipid microsphere; Procedure: Transrectal Ultrasound; Procedure: Biopsy of Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy
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.
Measured: Up to 2 years
Secondary outcomes (2)
PCa detection rate of 3D mp-US
Categorical data will be summarized as counts and percentages (or proportions) and continuous data will be summarized with descriptive statistics such as mean, SD, median, and range. Continuous data will be analyzed using t-tests, or log-rank tests if data are not normally distributed. Variance is expressed through 95% confidence intervals and a significance level of 5% with Bonferroni correction for multiple comparisons will be used to control the group-wise error of the study for individual comparisons.
Measured: Up to 2 years
Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI
Will evaluate the accuracty of the optimal logistic model combining the mp-US elements as well as the prostate specific antigen, prostate specific antigen velocity and other biological variables.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study startOct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Eindhoven University of Technology, Eigen, GE Healthcare
- Responsible party
- Principal investigator, Flemming Forsberg, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024772
- Sponsor's protocol ID
- iRISID-2022-1191
- Other IDs
- JT 20767
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Diagnosis by Multiparametric Ultrasound (Clinical)
- ClinicalTrials.gov ID
- NCT06024772
- Acronym / sponsor ID
- iRISID-2022-1191
- Conditions
- Prostate Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Eindhoven University of Technology, Eigen, GE Healthcare
- Study start
- Oct 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies) | Experimental | Procedure: ultiparametric Magnetic Resonance Imaging, Drug: Perflutren lipid microsphere, Procedure: Transrectal Ultrasound, Procedure: Biopsy of ProstatePatients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultiparametric Magnetic Resonance ImagingAlso: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRIUndergo mp-MRI | Procedure or surgery | Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies) |
| Perflutren lipid microsphereAlso: DefinityGiven IV | Drug | Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies) |
| Transrectal UltrasoundAlso: endorectal ultrasound, ERUS, TRUSUndergo transrectal mp-US | Procedure or surgery | Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies) |
| Biopsy of ProstateAlso: Prostate Biopsy, Prostatic BiopsyUndergo prostate biopsies | Procedure or surgery | Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies) |
Primary outcome
Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy
Time frame: Up to 2 years
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.
2 secondary outcomes
PCa detection rate of 3D mp-US
Time frame: Up to 2 years
Accuracy of PCa detection by biopsy using the optimal logistical model based around mp-US compared to the optimal logistical model based around mp-MRI
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ultiparametric Magnetic Resonance Imaging, Perflutren lipid microsphere and Transrectal Ultrasound in people with Prostate Carcinoma, run by Thomas Jefferson University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flemming Forsberg, PhD (215-955-4870, Flemming.Forsberg@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate cancer (PCa) detection rate of 3-dimensional (3D) multiparametric ultrasound (mp-US) combined with systematic biopsy (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.