Micro-Ultrasound for Prostate Cancer Detection

Overseen By Merdie Delfin

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Radiation, Focal treatment, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if micro-ultrasound, an imaging technique, can more effectively identify and characterize prostate cancer tumors than the usual method, multiparametric MRI. By providing real-time images, micro-ultrasound might simplify and reduce the cost of targeting prostate cancer treatments, potentially decreasing the need for extensive surgery. Men with biopsy-confirmed prostate cancer, scheduled for prostate removal surgery, and who have had an MRI in the past year, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future prostate cancer treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that micro-ultrasound is safe for prostate cancer detection?

Research has shown that micro-ultrasound is a promising tool for detecting prostate cancer. It provides real-time, clear images, helping doctors better identify cancerous areas. This suggests it might be more accurate than traditional methods like multiparametric MRI.

Regarding safety, current research has not shown any serious side effects with micro-ultrasound. As a non-invasive imaging technique, it is generally easy on the body. Its use in other prostate cancer studies suggests it is safe. However, as with any procedure, a small chance of minor discomfort or irritation remains. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about micro-ultrasound for prostate cancer detection because it offers a promising new way to visualize cancerous tissues more clearly and in real time. Unlike the standard transrectal ultrasound (TRUS) and multiparametric MRI (mpMRI), micro-ultrasound provides a higher resolution image, which could lead to more accurate detection and diagnosis of prostate cancer. This technique could enhance the precision of biopsies and potentially reduce the need for invasive procedures. By improving the detection capabilities, micro-ultrasound may lead to earlier and more effective interventions, ultimately benefiting patient outcomes.

What evidence suggests that micro-ultrasound is effective for prostate cancer detection?

Research has shown that micro-ultrasound, which participants in this trial may undergo, effectively detects prostate cancer. Studies indicate it can identify cancer as well as the commonly used MRI-guided biopsy. One study found that micro-ultrasound correctly identified 89% of those with the disease, demonstrating its accuracy in finding significant prostate cancer. Additionally, micro-ultrasound provides real-time images, potentially simplifying and reducing the cost of treatment. Overall, these findings suggest that micro-ultrasound could be a promising tool for detecting prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Leonard S. Marks

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men with biopsy-proven prostate cancer, a Gleason grade of at least 3+3, and who have had an mpMRI within the last year. Their prostate must be no larger than 6 cm across. They should be scheduled for a radical prostatectomy but haven't had prior radiation or focal treatments for cancer and can undergo transrectal ultrasound.

Inclusion Criteria

I am scheduled for a surgery to remove my prostate.

I had a special MRI for prostate cancer within the last year.

My prostate cancer is confirmed by biopsy and is aggressive.

Exclusion Criteria

I have had radiation or a specific treatment for prostate cancer.

Inability to have a transrectal ultrasound scan

Maximum posterior-to-anterior prostate dimension greater than 6 cm

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Patients may undergo transrectal micro-ultrasound scan (TRUS) prior to standard-of-care radical prostatectomy

1-2 weeks

1 visit (in-person)

Post-Prostatectomy Analysis

Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Micro-Ultrasound

Trial Overview The study is testing if micro-ultrasound can better detect and outline prostate cancer tumors compared to standard imaging methods in patients set to have their prostates completely removed. The goal is to see if this method could lead to more targeted therapy and potentially reduce surgeries.

How Is the Trial Designed?

Group I: Diagnostic (TRUS) Experimental Treatment 3 Interventions

Patients may undergo TRUS prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Exact Imaging

Industry Sponsor

Trials

6

Recruited

2,700+

Phase One Foundation

Collaborator

Trials

5

Recruited

180+

Published Research Related to This Trial

In a study involving 1676 men, high-frequency micro-ultrasound (micro-US) did not show a significant advantage over conventional ultrasound (conv-US) for detecting clinically significant prostate cancer (csPCa) during prostate biopsies, with detection rates of 34.6% for micro-US and 36.6% for conv-US.

However, after implementing a training protocol for interpreting micro-US images, sensitivity for detecting csPCa improved significantly from 24.6% to 60.8%, indicating that training can enhance the effectiveness of this imaging technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy. Pavlovich, CP., Hyndman, ME., Eure, G., et al.[2022]

Micro-ultrasound (Micro-US) demonstrated a sensitivity of 76.5% and specificity of 76.6% in detecting prostate cancer index lesions, showing good reliability in diagnosis.

When compared to multiparametric MRI (mpMRI), Micro-US performed similarly, with mpMRI showing a sensitivity of 65.1% and higher specificity of 93.4%, indicating that Micro-US can be a viable alternative for prostate cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between Micro-Ultrasound and Multiparametric MRI Regarding the Correct Identification of Prostate Cancer Lesions. Lorusso, V., Kabre, B., Pignot, G., et al.[2022]

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]

High resolution micro-ultrasound (micro-u/s) offers a resolution of 70 μm, allowing for detailed visualization of prostate lesions and potentially superior sensitivity for detecting clinically significant prostate cancer compared to mpMRI.

Micro-u/s is a cost-effective and accessible alternative to mpMRI for prostate cancer imaging, with comparable specificity, making it a promising tool for diagnosis in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? Laurence Klotz, CM.[2021]

In a study of 100 patients with low-risk prostate cancer, micro-ultrasound (microUS) demonstrated high sensitivity (94.1%) for detecting clinically significant cancer (ISUP ≥ 2), making it a valuable tool for monitoring patients on active surveillance.

MicroUS can effectively identify suspicious lesions and may reduce the need for confirmatory biopsies, although it may miss some upgraded cases; it serves as a viable alternative to mpMRI in guiding targeted biopsies for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of microUltrasound at MRI-guided confirmatory biopsy in patients under active surveillance for low-risk prostate cancer. Maffei, D., Fasulo, V., Avolio, PP., et al.[2023]

In a study of 75 biopsy-naive men, high-resolution micro-ultrasound (microUS) combined with MRI significantly improved the detection of clinically significant prostate cancer (csPCa), identifying csPCa in 52% of cases during biopsies.

The Prostate Risk Identification using MicroUS (PRI-MUS) score was effective in stratifying cancer risk, with cores scoring PRI-MUS ≥3 showing a 3.5-fold higher likelihood of detecting csPCa compared to those scoring PRI-MUS ≤2, highlighting the potential of microUS as a valuable tool in prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of clinically significant prostate cancer by micro-ultrasound-informed systematic biopsy during MRI/micro-ultrasound fusion biopsy. Wang, B., Broomfield, S., Martín, AM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9954149/

Micro-Ultrasound: Current Role in Prostate Cancer ... In this case, using systematic biopsy as the reference standard may make microUS and mpMRI seem more effective in detecting prostate cancer.

2. uroweb.org uroweb.org/press-releases/high-resolution-ultrasound-could-enable-faster-prostate-cancer-diagnosis

High resolution ultrasound could enable faster prostate ... MicroUS was able to identify prostate cancer as effectively as MRI-guided biopsy, with very similar rates of detection across all three arms of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143925000870

Clinical-Prostate cancer Diagnostic performance of high ... The aim of this study was to evaluate the diagnostic outcomes of MRI-ultrasound fusion targeted biopsy in detecting clinically significant prostate cancer ( ...

4. mdpi.com mdpi.com/2563-6499/4/6/465

Comparing the Diagnostic Performance of Micro ... The pooled sensitivity and specificity for micro-ultrasound-guided biopsies detecting clinically significant prostate cancer were 89% (95% CI 83 to 93) and 31% ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pros.24862

Optimizing Prostate Cancer Diagnostic Work‐Up Through ... In the multivariable Cox regression model, men with a negative mUS result demonstrated significantly lower risk of undergoing prostate biopsy ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8322825/

Micro-Ultrasound: a way to bring imaging for prostate ... In summary, microultrasound presents a promising technology for further improving urological imaging and allows for the possibility of returning prostate cancer ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06626022

NCT06626022 | Screening for Prostate Cancer Using High ... Also called a data safety and ... Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107814392500345X

Microultrasound-targeted biopsies in patients with ... Micro-ultrasound is an emerging imaging tool for prostate cancer diagnosis. · Provides real-time, high-resolution guidance for targeted prostate ...

9. mdpi.com mdpi.com/2379-139X/11/7/80

Micro-Ultrasound in the Detection of Clinically Significant ... The growing body of evidence evaluating micro-US for prostate cancer detection suggests that it may be a promising alternative or complement to mpMRI for the ...

10. uroweb.org uroweb.org/news/new-evidence-signals-a-shift-in-prostate-cancer-diagnosis-and-treatment

New evidence signals a shift in prostate cancer diagnosis ... New evidence signals a shift in prostate cancer diagnosis and treatment · Micro-ultrasound proves its worth in the OPTIMUM trial · RAMPP trial ...