Multiparametric Ultrasound + MRI for Prostate Cancer

Recruiting at 1 trial location

Overseen By Flemming Forsberg, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Thomas Jefferson University

Disqualifiers: Investigational drugs, Hypersensitivity, Previous treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are participating in another clinical trial involving an investigational drug, you must wait 30 days before joining this one.

What data supports the effectiveness of this treatment for prostate cancer?

Research shows that combining multiparametric ultrasound and MRI can improve the detection of significant prostate cancer, helping to better identify and target areas for biopsy. This approach may reduce the chances of missing important cancerous areas while avoiding unnecessary procedures. ^{1 2 3 4 5}

Is multiparametric ultrasound and MRI for prostate cancer safe?

Research indicates that MRI-guided focused ultrasound for prostate cancer is generally safe, with no major treatment-related adverse events reported in a study involving 44 men. This suggests that the procedure is well-tolerated in humans. ^{4 6 7 8 9}

How does the treatment Multiparametric Ultrasound differ from other treatments for prostate cancer?

Multiparametric Ultrasound is unique because it combines different ultrasound techniques, like B-mode, shear wave elastography, and contrast-enhanced ultrasound, to improve the detection and localization of prostate cancer. Unlike multiparametric MRI, which is less available, this ultrasound approach offers a more accessible option for diagnosing and monitoring prostate cancer. ^{1 2 4 5 10}

Eligibility Criteria

This trial is for adult men who need a prostate biopsy due to high PSA levels, increased PSA velocity, or abnormal rectal exams. They must be willing to consent to an ultrasound study with additional biopsies and have not had any treatments for prostate cancer including hormone therapy.

Inclusion Criteria

I am willing to sign consent for a special ultrasound and extra biopsies of my prostate.

I am scheduled for a prostate biopsy due to high PSA or an abnormal exam.

Exclusion Criteria

I have received treatment for prostate cancer, including hormone therapy.

Clinically unstable, severely ill, or moribund as per treating physician

You have a known or suspected allergy to perflutren, polyethylene glycol (PEG), or any other ingredient in Definity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

Up to 2 years

Treatment Details

Interventions

• Biopsy of Prostate
• Multiparametric Magnetic Resonance Imaging
• Multiparametric Ultrasound
• Perflutren lipid microsphere

Trial Overview The trial compares contrast-enhanced multiparametric ultrasound (mp-US) using Definity with standard multiparametric MRI (mp-MRI) in diagnosing significant prostate cancer. It aims to see if mp-US can more accurately guide targeted biopsies.

Participant Groups

Group I: Diagnostic (mp-MRI, Definity, mp-US, prostate biopsies) Experimental Treatment 4 Interventions

Patients undergo mp-MRI, receive Definity IV, and undergo transrectal mp-US and prostate biopsies on study.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Amsterdam UMC, location VUmc

Collaborator

Trials

421

Recruited

218,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Eindhoven University of Technology

Collaborator

Trials

25

Recruited

4,300+

Eigen

Collaborator

Trials

3

Recruited

560+

Findings from Research

In a prospective phase II trial involving 44 men with intermediate-risk prostate cancer, MRI-guided focal therapy using high-intensity focused ultrasound was found to be safe, with no major treatment-related adverse events reported.

At the 5-month follow-up, 93% of participants were free of clinically significant prostate cancer at the treatment site, indicating promising early oncologic outcomes, while functional outcomes related to erectile function and urinary symptoms remained stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial. Ghai, S., Finelli, A., Corr, K., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

The combined value of mpUS and mpMRI-TRUS fusion for the diagnosis of clinically significant prostate cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Multiparametric ultrasound in the diagnosis of prostate cancer. [2021]

3. Romania pubmed.ncbi.nlm.nih.gov

Prostate ultrasound: back in business! [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The role of diagnostic ultrasound imaging for patients with known prostate cancer within an active surveillance pathway: A systematic review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Multiparametric Ultrasound for Prostate Cancer Detection and Localization: Correlation of B-mode, Shear Wave Elastography and Contrast Enhanced Ultrasound with Radical Prostatectomy Specimens. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The CADMUS trial - Multi-parametric ultrasound targeted biopsies compared to multi-parametric MRI targeted biopsies in the diagnosis of clinically significant prostate cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

An ultrasound-responsive dual-modal US/T1 -MRI contrast agent for potential diagnosis of prostate cancer. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the ESUR PI-RADS scoring system for multiparametric MRI of the prostate with targeted MR/TRUS fusion-guided biopsy at 3.0 Tesla. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Multiparametric ultrasound versus multiparametric MRI to diagnose prostate cancer (CADMUS): a prospective, multicentre, paired-cohort, confirmatory study. [2022]