Imaging Agent + Ultrasound for Prostate Cancer

Not currently recruiting at 1 trial location

Overseen By Flemming Forsberg, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Thomas Jefferson University

Disqualifiers: Investigational drug, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special imaging agent, perflutren lipid microspheres, can help doctors better visualize prostate cancer on ultrasound images. These tiny gas-filled bubbles typically enhance heart imaging but may also improve prostate cancer diagnosis. Men planning to undergo surgery to remove prostate cancer, who have not received previous treatments, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking diagnostic advancement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging agent and ultrasound technique is safe for diagnosing prostate cancer?

Research has shown that perflutren lipid microspheres, also known as Definity, are generally safe for use in ultrasound scans. The FDA has approved this contrast agent for heart imaging. It works by creating tiny bubbles that enhance ultrasound images.

Serious reactions are rare but can occur, potentially affecting the heart and lungs, and in very rare cases, leading to death. Most people experience no issues with the treatment. The bubbles do not remain in the body long and are quickly expelled through breathing.

Prospective trial participants should discuss any health conditions, particularly those related to the heart or lungs, with their doctor. This discussion will help ensure the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using perflutren lipid microspheres with ultrasound for prostate cancer because it offers a new approach to imaging. Unlike traditional methods, which often rely solely on MRI or CT scans, this treatment involves an innovative combination of microbubbles and ultrasound to enhance imaging clarity. The microspheres act as contrast agents, improving the visibility of prostate tumors during ultrasound procedures. This could potentially lead to more precise tumor detection and better treatment planning for patients.

What evidence suggests that this imaging agent and ultrasound method is effective for diagnosing prostate cancer?

Research shows that tiny gas-filled bubbles, called perflutren lipid microspheres, can enhance ultrasound imaging of prostate tissue. These bubbles clarify ultrasound images. In this trial, participants will receive perflutren lipid microspheres and undergo ultrasound to evaluate this method, known as contrast-enhanced ultrasound. Past studies have shown promise in better identifying problem areas in the prostate. This technique aims to improve prostate cancer diagnosis accuracy without invasive procedures. Early findings suggest it might help doctors detect cancerous tissues more effectively by highlighting blood flow patterns linked to tumors. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for men at least 18 years old who are scheduled for prostate removal due to cancer and can consent to the study. It's not for those with allergies to perflutren or Definity components, severely ill patients, those previously treated for prostate cancer, or anyone in a drug trial within the last month.

Inclusion Criteria

I agree to have a special ultrasound of my prostate before surgery.

I am scheduled for a surgery to remove my prostate due to cancer.

Exclusion Criteria

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive perflutren lipid microspheres intravenously and undergo ultrasound imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Perflutren Lipid Microspheres

Trial Overview The study tests if an imaging agent called Definity (perflutren lipid microspheres) combined with ultrasound can help diagnose prostate cancer non-invasively. The agent creates enhanced images by showing up as tiny bubbles on the ultrasound.

How Is the Trial Designed?

Group I: Diagnostic (perflutren lipid microspheres, ultrasound) Experimental Treatment 2 Interventions

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

Perflutren Lipid Microspheres is already approved in United States for the following indications:

Approved in United States as Definity for:

• Adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 36 men with prostate carcinoma, treatment with anti-androgens led to significant reductions in prostate vascularity as measured by microbubble-enhanced ultrasound, with marked changes observed within one week.

The decline in vascular enhancement closely correlated with decreases in PSA levels, indicating that microbubble ultrasound can effectively monitor early treatment responses in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative microbubble enhanced transrectal ultrasound as a tool for monitoring hormonal treatment of prostate carcinoma. Eckersley, RJ., Sedelaar, JP., Blomley, MJ., et al.[2016]

High-resolution micro-ultrasound demonstrated a higher sensitivity (94%) for detecting clinically significant prostate cancer compared to multiparametric MRI (90%), suggesting it may be a more effective imaging option.

Micro-ultrasound offers a low-cost and accessible alternative for prostate cancer screening and targeted biopsy, with similar specificity to mpMRI, making it a promising tool for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis. Klotz, L., Lughezzani, G., Maffei, D., et al.[2022]

Magnetic resonance-guided focused ultrasound (MRgFUS) is a non-invasive treatment for low-risk prostate cancer that aims to effectively control cancer while preserving quality of life by minimizing side effects associated with traditional therapies.

This study reports the first North American clinical experience with MRgFUS for localized prostate cancer, highlighting its ability to accurately target and monitor tumor ablation in real time, which could represent a significant advancement in prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal magnetic resonance guided focused ultrasound for prostate cancer: Initial North American experience. Lindner, U., Ghai, S., Spensieri, P., et al.[2021]

In a first-in-human study involving 24 patients with prostate cancer, the ultrasound molecular contrast agent BR55 was found to be safe, with no serious adverse events reported during or after its administration.

BR55 successfully detected 50% of malignant lesions identified by histopathology, and with an improved imaging protocol, this detection rate increased to 68%, indicating its potential effectiveness for cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Ultrasound Molecular Imaging With a VEGFR2-Specific Ultrasound Molecular Contrast Agent (BR55) in Prostate Cancer: A Safety and Feasibility Pilot Study. Smeenge, M., Tranquart, F., Mannaerts, CK., et al.[2022]

Ultrasound targeted microbubble destruction (UTMD) combined with docetaxel and Rose Bengal significantly reduced cancer cell viability in pre-clinical prostate cancer models, outperforming standard docetaxel treatment alone.

This innovative approach allowed for a 91% reduction in the docetaxel dose needed, resulting in better tolerance and less toxicity compared to traditional chemotherapy, making it a promising alternative for advanced prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound targeted microbubble destruction using docetaxel and Rose Bengal loaded Microbubbles for targeted Chemo-Sonodynamic therapy treatment of prostate cancer. McKaig, T., Logan, K., Nesbitt, H., et al.[2023]

Magnetic resonance-guided high frequency focused ultrasound (MRgFUS) is a safe and feasible method for noninvasively treating low-intermediate risk prostate cancer, with acceptable short-term oncologic outcomes observed in a study of eight patients.

After treatment, 60% of target lesions showed no disease on biopsy, and the mean PSA levels decreased significantly from 5.06 ng/ml to 3.4 ng/ml at 6 months, indicating effective disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance guided focused high frequency ultrasound ablation for focal therapy in prostate cancer - phase 1 trial. Ghai, S., Perlis, N., Lindner, U., et al.[2020]

The study developed PSMA-targeted nanosystems that combine photothermal therapy and chemotherapy, showing significant inhibition of prostate cancer cell proliferation both in vitro and in vivo.

These nanosystems utilize ultrasound-enhanced imaging and photoacoustic imaging for precise targeting and effective drug delivery, highlighting their potential as a novel therapeutic approach for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser-activated nanoparticles for ultrasound/photoacoustic imaging-guided prostate cancer treatment. Xiao, L., Wu, Y., Dai, J., et al.[2023]

The study successfully developed prostate-specific membrane antigen (PSMA) single-chain variable fragment (scFv)-loaded nanobubbles (NBs) that specifically bind to PSMA-expressing prostate cancer cells, demonstrating their potential as targeted ultrasound contrast agents.

In vivo tests showed that these targeted NBs significantly enhanced ultrasound contrast in tumors expressing PSMA compared to nontargeted NBs, indicating their efficacy for both imaging and potential delivery of targeted therapies for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimized Anti-Prostate-Specific Membrane Antigen Single-Chain Variable Fragment-Loaded Nanobubbles as a Novel Targeted Ultrasound Contrast Agent for the Diagnosis of Prostate Cancer. Ding, Y., Cao, Q., Qian, S., et al.[2021]

The study introduces PSMA-targeted nanobubbles (PSMA-NB) that enhance the detection of prostate cancer by specifically accumulating in tumors, which allows for real-time imaging using clinical ultrasound.

Results from mouse models show that these targeted nanobubbles significantly improve tumor accumulation and retention, suggesting a promising approach to increase the sensitivity and specificity of prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real time ultrasound molecular imaging of prostate cancer with PSMA-targeted nanobubbles. Perera, RH., de Leon, A., Wang, X., et al.[2021]

A new animal model using dogs with induced prostate cancer demonstrated that the ultrasonographic contrast agent Sonazoid significantly improved the visualization of tumor vascularity and characteristics, enhancing detection capabilities.

The accuracy of detecting prostate tumors increased from 67% to 87% when using the contrast agent in gray scale phase inversion harmonic imaging, confirming its effectiveness for better imaging in veterinary applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced transrectal ultrasonography of a novel canine prostate cancer model. Forsberg, F., Johnson, DK., Merton, DA., et al.[2019]

In a study of 530 men with nonmetastatic prostate cancer, combining short-term neoadjuvant androgen deprivation therapy (NADT) with high-intensity focused ultrasound (HIFU) significantly improved the 3-year disease-free survival rate for patients with intermediate and high-risk cancer.

Despite the NADT group having worse disease characteristics at baseline, the addition of NADT did not increase the risk of complications compared to HIFU alone, indicating a safe and effective treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of short-term androgen deprivation with high-intensity focused ultrasound in the treatment of prostate cancer in Japan. Sumitomo, M., Hayashi, M., Watanabe, T., et al.[2016]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-01765

An Imaging Agent (Perflutren Lipid Microspheres) with ... This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9084632/

Contrast-Enhanced Transrectal Ultrasound in Focal Therapy ... Contrast-enhanced transrectal ultrasound (CeTRUS) is an emerging imaging technique in prostate cancer (PCa) diagnosis and treatment.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02967458?term=AREA%5BBasicSearch%5D(lantheus)&rank=7&checkSpell=

NCT02967458 | Detection of High Grade Prostate Cancer ... The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound ...

4. definityimaging.com definityimaging.com/

DEFINITY® (Perflutren Lipid Microsphere) Diagnostic ... DEFINITY is a diagnostic ultrasound enhancing agent that uses advanced microbubble technology to opacify the left ventricular chamber.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10763448/

Pharmacokinetics and pharmacodynamics of ... Definity is an ultrasound contrast agent consisting of phospholipids-encapsulated perfluoropropane (PFP), also known as perflutren, microspheres ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/021064s025s029lbl.pdf

Definity - accessdata.fda.gov The DEFINITY RT vial contains components that upon activation and dilution yield perflutren lipid microspheres. The unactivated vial contains a colorless ...

7. definityimaging.com definityimaging.com/safety

Safety Profile of DEFINITY® for Medical Imaging Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/021064s011lbl.pdf

Definity (perflutren) injection label - accessdata.fda.gov The perflutren lipid microspheres are composed of octafluoropropane encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1 ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/perflutren-lipid-microsphere-intravenous-route/description/drg-20067608

Perflutren lipid microsphere (intravenous route) Perflutren lipid microsphere injection is used during an echocardiogram to help diagnose or find problems in the heart.

10. go.drugbank.com go.drugbank.com/drugs/DB00556

Perflutren: Uses, Interactions, Mechanism of Action Perflutren, a diagnostic drug that is intended to be used for contrast enhancement during the indicated echocardiographic procedures, comprised of lipid-coated ...