Imaging Agent + Ultrasound for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Thomas Jefferson University
Disqualifiers: Investigational drug, Hypersensitivity, Previous treatment, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
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.
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 data supports the effectiveness of the treatment Perflutren Lipid Microspheres, Definity, Definity RT for prostate cancer?
Research shows that using microbubbles with ultrasound can help in targeting and treating prostate cancer more effectively. For example, a study found that using ultrasound with microbubbles to deliver chemotherapy was more effective and better tolerated than traditional methods. This suggests that similar approaches, like using Perflutren Lipid Microspheres with ultrasound, could also be beneficial.12345
Is the imaging agent used with ultrasound for prostate cancer safe for humans?
How is the treatment with Perflutren Lipid Microspheres for prostate cancer different from other treatments?
This treatment uses Perflutren Lipid Microspheres, which are tiny bubbles that enhance ultrasound imaging, making it easier to detect prostate cancer. Unlike traditional imaging methods, this approach combines an imaging agent with ultrasound to improve the visibility of cancerous tissues, potentially offering a more accessible and cost-effective option.1591011
Eligibility Criteria
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 am a man aged 18 or older.
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
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Trial Timeline
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
Treatment Details
Interventions
- Perflutren Lipid Microspheres (Imaging Agent)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Diagnostic (perflutren lipid microspheres, ultrasound)Experimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphia, PA
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Who Is Running the Clinical Trial?
Thomas Jefferson UniversityLead Sponsor
References
First-in-Human Ultrasound Molecular Imaging With a VEGFR2-Specific Ultrasound Molecular Contrast Agent (BR55) in Prostate Cancer: A Safety and Feasibility Pilot Study. [2022]BR55, a vascular endothelial growth factor receptor 2 (VEGFR2)-specific ultrasound molecular contrast agent (MCA), has shown promising results in multiple preclinical models regarding cancer imaging. In this first-in-human, phase 0, exploratory study, we investigated the feasibility and safety of the MCA for the detection of prostate cancer (PCa) in men using clinical standard technology.
Quantitative microbubble enhanced transrectal ultrasound as a tool for monitoring hormonal treatment of prostate carcinoma. [2016]We quantified changes in prostate carcinoma vascularity treated with anti-androgens using color Doppler and power transrectal ultrasound in combination with microbubble contrast agent Levovist.
Efficacy of short-term androgen deprivation with high-intensity focused ultrasound in the treatment of prostate cancer in Japan. [2016]To determine whether combining short-term neoadjuvant androgen deprivation therapy (NADT) with high-intensity focused ultrasound (HIFU) had a significant benefit in a large population of men with nonmetastatic prostate cancer (CaP).
Ultrasound targeted microbubble destruction using docetaxel and Rose Bengal loaded Microbubbles for targeted Chemo-Sonodynamic therapy treatment of prostate cancer. [2023]Docetaxel (DTX) chemotherapy is commonly used in the treatment of patients with advanced prostate cancer demonstrating modest improvements in survival. As these patients are often elderly and the chemotherapy treatment is not targeted, it is often poorly tolerated. More targeted approaches that increase therapeutic efficacy yet reduce the amount of toxic chemotherapy administered are needed. In this manuscript, we investigate the potential of ultrasound targeted microbubble destruction (UTMD) to deliver a combination of docetaxel chemotherapy and Rose Bengal mediated sonodynamic therapy (SDT) in pre-clinical prostate cancer models. A Rose Bengal modified phospholipid was synthesized and used as a component lipid to prepare a microbubble (MB) formulation that was also loaded with DTX. The DTX-MB-RB formulation was used in the UTMD mediated treatment of androgen sensitive and androgen resistant 3D spheroid and murine models of prostate cancer. Results from the 3D spheroid experiments showed UTMD mediated DTX-MB-RB chemo-sonodynamic therapy to be significantly more effective at reducing cell viability than UTMD mediated DTX or SDT treatment alone. In an androgen sensitive murine model of prostate cancer, UTMD mediated DTX-MB-RB chemo-sonodynamic therapy was as effective as androgen deprivation therapy (ADT) at controlling tumour growth. However, when both treatments were combined, a significant improvement in tumour growth delay was observed. In an androgen resistant murine model, UTMD mediated DTX-MB-RB chemo-sonodynamic therapy was significantly more effective than standard DTX monotherapy. Indeed, the DTX dose administered using the DTX-MB-RB formulation was 91% less than standard DTX monotherapy. As a result, UTMD mediated DTX-MB-RB treatment was well tolerated while animals treated with DTX monotherapy displayed significant weight loss which was attributed to acute toxic effects. These results highlight the potential of UTMD mediated DTX-MB-RB chemo-sonodynamic therapy as a targeted, well tolerated alternative treatment for advanced prostate cancer.
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. [2021]To prepare optimized prostate-specific membrane antigen (PSMA) single-chain variable fragment (scFv)-loaded nanobubbles (NBs) as a novel targeted ultrasound (US) contrast agent for diagnosis and treatment of prostate cancer (PCa).
Focal magnetic resonance guided focused ultrasound for prostate cancer: Initial North American experience. [2021]The treatment of low-risk prostate cancer is a common clinical dilemma between standard curative whole gland therapy (and its associated quality of life diminishing side effects) and active surveillance (and its low, but real, risk of progression). The goal of focal therapy in low-risk prostate cancer is to achieve the best balance between cancer control and maintenance of quality of life. Magnetic resonance-guided focused ultrasound (MRgFUS) surgery is a non-invasive thermal ablation method that integrates magnetic resonance imaging for target identification, treatment planning and closed-loop control of thermal deposition and focused ultrasound for thermal ablation of the tumour target. This novel transrectal system allows for tumour localization, targeting and monitoring of tumour target ablation in real time, while simultaneously preserving adjacent normal tissue thereby minimizing the side effects of standard curative surgical or radiation therapy. We report the first North American clinical experience of treatment of localized prostate cancer with focal MR-guided transrectal focused ultrasound (clinicaltrial.gov identifier NCT01226576).
Magnetic resonance guided focused high frequency ultrasound ablation for focal therapy in prostate cancer - phase 1 trial. [2020]To evaluate the feasibility and safety of focal therapy for low-intermediate risk prostate cancer (PCa) with magnetic resonance-guided high frequency focused ultrasound (MRgFUS) METHODS: This IRB-approved phase 1 prospective study enrolled eight patients with prostate specific antigen (PSA) ≤ 10 ng/ml, ≤ cT2a and Gleason score ≤ 7 (4 + 3) disease following informed consent. Under MRI guidance, focused high frequency ultrasound energy was delivered to ablate the target tissue. Treatment-related adverse events were recorded. Oncologic outcomes were evaluated with multiparametric MRI, PSA and TRUS biopsy at 6 months following treatment.
Laser-activated nanoparticles for ultrasound/photoacoustic imaging-guided prostate cancer treatment. [2023]Prostate cancer (PCa) is the most common malignant tumor in men. Prostate-specific membrane antigen (PSMA), which is overexpressed on the surface of Prostate cancer cells, may serve as a potential therapeutic target. Recently, image-guided and targeted therapy for prostate cancers has attracted much attention by using Prostate-specific membrane antigen targeting nanoparticle. In this study, we produced PSMA-targeted light-responsive nanosystems. These nanosystems of liquid perfluorocarbon cores and polymer shells were loaded with the photosensitizer IR780 and therapeutic drugs paclitaxel. The liquid perfluorocarbon (PFP) in nanoparticles can perform ultrasound-enhanced imaging by liquid-gas transition and promote the deliver and release of paclitaxel. IR780 can perform photothermal therapy (PTT) guided by photoacoustic (PA) imaging. Combination treatment with photothermal therapy and chemotherapy exhibited excellent inhibition of cell proliferation in vitro and a significant therapeutic effect in vivo. In conclusion, we successfully formulated PSMA-targeted nanosystems with precision targeting and ultrasound/PA dual-modality imaging for anti-tumor effects.
Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis. [2022]High-resolution micro-ultrasound has the capability of imaging prostate cancer based on detecting alterations in ductal anatomy, analogous to multiparametric magnetic resonance imaging (mpMRI). This technology has the potential advantages of relatively low cost, simplicity, and accessibility compared to mpMRI. This multicenter, prospective registry aims to compare the sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of mpMRI with high-resolution micro-ultrasound imaging for the detection of clinically significant prostate cancer.
Real time ultrasound molecular imaging of prostate cancer with PSMA-targeted nanobubbles. [2021]Contrast-enhanced ultrasound with microbubbles has shown promise in detection of prostate cancer (PCa), but sensitivity and specificity remain challenging. Targeted nanoscale-contrast agents with improved capability to accumulate in tumors may result in prolonged signal enhancement and improved detection of PCa with ultrasound. Here we report nanobubbles (NB) that specifically targets prostate specific membrane antigen (PSMA) overexpressed in PCa. The PSMA-targeted-NB (PSMA-NB) were utilized to simultaneously image dual-flank PCa (PSMA-positive PC3pip and PSMA-negative PC3flu) to examine whether the biomarker can be successfully detected and imaged in a mouse model. Results demonstrate that active targeting rapidly and selectively enhances tumor accumulation and tumor retention. Importantly, these processes could be visualized and quantified, in real-time, with clinical ultrasound. Such demonstration of the immense yet underutilized potential of ultrasound in the molecular imaging area can open the door to future opportunities for improving sensitivity and specificity of cancer detection using parametric NB-enhanced ultrasound imaging.
Contrast-enhanced transrectal ultrasonography of a novel canine prostate cancer model. [2019]This study evaluated the utility of a new animal model for prostate cancer imaging using a new ultrasonographic contrast agent (Sonazoid [NC100100]; Amersham Health, Oslo, Norway), for prostate cancer detection.