Multiparametric Ultrasound + MRI for Prostate Cancer

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for detecting significant prostate cancer: a special ultrasound with a contrast agent (perflutren lipid microsphere) and an MRI scan. The researchers aim to determine if the ultrasound method can accurately guide a biopsy, similar to the MRI. Men eligible for this trial are those scheduled for a prostate biopsy due to elevated prostate-specific antigen (PSA) levels or an abnormal prostate exam. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking advancements in prostate cancer diagnosis.

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 prior data suggests that these diagnostic techniques are safe for prostate cancer detection?

Research has shown that multiparametric ultrasound (mp-US) is generally safe and well-tolerated by patients. This technique aims to improve cancer detection, and studies have not reported any major safety issues. The contrast agent used, perflutren lipid microsphere, is also considered safe and is used in other imaging tests without major concerns.

Similarly, multiparametric MRI (mp-MRI) is known for its safety and effectiveness in imaging. It is commonly used to diagnose prostate cancer and has a strong safety record in clinical settings.

In summary, both mp-US with perflutren lipid microsphere and mp-MRI are generally well-tolerated and considered safe based on current research and their use in medical imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using multiparametric ultrasound (mp-US) combined with MRI for prostate cancer because it offers a more detailed and accurate way to visualize the prostate and detect cancerous lesions. Traditional methods, like standard ultrasound and MRI used separately, might miss smaller or subtler tumors. The multiparametric approach combines different imaging techniques and uses a contrast agent called Definity to enhance the visualization, potentially leading to earlier and more precise diagnosis. This could ultimately improve treatment decisions and outcomes for patients by catching cancer earlier and more accurately determining its extent.

What evidence suggests that this trial's diagnostic techniques could be effective for prostate cancer?

This trial will evaluate the effectiveness of multiparametric ultrasound (mp-US) and multiparametric MRI (mp-MRI) in diagnosing prostate cancer. Research has shown that mp-US can detect significant prostate cancers, correctly identifying these cancers 55% to 74% of the time. However, it detects slightly fewer significant prostate cancers compared to mp-MRI. In contrast, mp-MRI excels at finding and pinpointing prostate cancer, with a high accuracy rate of 89%. Both mp-US and mp-MRI offer advantages: mp-MRI is more accurate, but mp-US might lead to more patients being selected for further testing. Participants in this trial will undergo both mp-US and mp-MRI, along with other diagnostic procedures, to assess their effectiveness in detecting prostate cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4495493/

Multiparametric-MRI in diagnosis of prostate cancer - PMC Multiparametric-magnetic resonance imaging (mp-MRI) has shown promising results in diagnosis, localization, risk stratification and staging of clinically ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.6_suppl.224

Effectiveness of early diagnosis for prostate cancer based ... Using mpMRI was estimated to result in an additional 126 and 118 fewer deaths per 100,000 if mpMRI was used in conjunction with SB (S2) or with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107814392400485X

mpMRI in prostate cancer screening and diagnosis This contemporary review evaluates the most recent literature on the role of mpMRI in the screening and diagnosis of prostate cancer.

4. aafp.org aafp.org/pubs/afp/issues/2022/0600/p665.html

Multiparametric MRI for the Evaluation of Prostate Cancer By targeting suspicious areas of the prostate, the median rate of significant prostate cancer detection was 33% with mpMRI vs. 24% with biopsy alone. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7443696/

Five-year Outcomes of Magnetic Resonance Imaging–based ... Approximately 85% and 72% of patients remain on MRI-led AS at 3 and 5 yr, respectively. MRI visibility and Gleason grade are determining factors of EFS and time ...

6. auanet.org auanet.org/guidelines-and-quality/guidelines/other-clinical-guidance/mri-of-the-prostate-sop

Prostate Cancer Multi-parametric MRI (mpMRI) has been proven to be a valuable tool in the diagnostic and management pathway in men at risk of prostate cancer.

7. pubs.rsna.org pubs.rsna.org/doi/10.1148/rycan.240269

Multiparametric MRI before and after Focal Therapy for ... mpMRI consistently underestimates the size and extent of prostate cancer, particularly for larger tumors and tumors containing high-grade cancer ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S030228382402640X

Evaluating Biparametric Versus Multiparametric Magnetic ... Our results demonstrate that biparametric MRI (bpMRI) is noninferior to multiparametric MRI (mpMRI) in diagnosing clinically significant prostate cancer, as ...