Prostate CarcinomaPhase 3NCT05336786
Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
A Phase 3 study testing Perflutren Lipid Microspheres and Ultrasound in people with Prostate Carcinoma, run by Thomas Jefferson University at 2 sites in 2 countries.
Trial summary
This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. 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?
- Perflutren Lipid Microspheres and Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jun 2022to 26 May 2026
- 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 radical prostatectomy for treatment of prostate cancer
- Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy
- 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, 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.
2 sites in 2 countries
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.
Read the detailed description
PRIMARY OBJECTIVES:
- To collect multiparametric ultrasound (mp-US) data on 70 patients within 30 days of their radical prostatectomy.
II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach.
OUTLINE:
Patients receive perflutren lipid microspheres intravenously (IV) over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres during ultrasound.
After completion of study, patients are followed up for 30 days.
- Conditions
- Prostate Carcinoma
- Being tested
- Perflutren Lipid Microspheres, Ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren Lipid MicrospheresDrug
Also called Definity
Given IV
UltrasoundProcedure or surgery
Undergo ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (perflutren lipid microspheres, ultrasound) | Experimental | Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres Receives: Drug: Perflutren Lipid Microspheres; Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start15 Jun 2022
- Primary completion26 May 2025
- Study completion26 May 2026 (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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Flemming Forsberg, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336786
- Sponsor's protocol ID
- 21G.1212
- Other IDs
- R01CA252311, JT 18100
- Status last verified
- Aug 2025
- First submitted
- 7 Apr 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
- ClinicalTrials.gov ID
- NCT05336786
- Acronym / sponsor ID
- 21G.1212
- Conditions
- Prostate Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2026 (estimated)
- First posted
- 20 Apr 2022 (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 investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.
Detailed description
PRIMARY OBJECTIVES:
- To collect multiparametric ultrasound (mp-US) data on 70 patients within 30 days of their radical prostatectomy.
II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach.
OUTLINE:
Patients receive perflutren lipid microspheres intravenously (IV) over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres during ultrasound.
After completion of study, patients are followed up for 30 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (perflutren lipid microspheres, ultrasound) | Experimental | Drug: Perflutren Lipid Microspheres, Procedure: UltrasoundPatients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres |
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 radical prostatectomy for treatment of prostate cancer
- Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy
- 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, 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 |
|---|---|---|
| Perflutren Lipid MicrospheresAlso: DefinityGiven IV | Drug | Diagnostic (perflutren lipid microspheres, ultrasound) |
| UltrasoundUndergo ultrasound | Procedure or surgery | Diagnostic (perflutren lipid microspheres, ultrasound) |
Primary outcome
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
Time frame: Up to 12 months
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 4 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Perflutren Lipid Microspheres and 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate (time frame: Up to 12 months). 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 4 Sep 2025.