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

86 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the ability of micro-ultrasound to detect and characterize prostate cancer tumors in patients undergoing radical prostatectomy (removal of the entire prostate and some of the tissue around it). Usually multiparametric magnetic resonance imaging is used for the detection and targeted therapy of prostate cancer, but its accuracy remains imperfect. Micro-ultrasound may be superior as it provides real-time tumor visualization which may simplify and improve prostate cancer targeted therapy. This may also reduce the need for and substantial costs of radical prostatectomy.

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 data supports the effectiveness of the treatment Micro-Ultrasound for prostate cancer detection?

Research shows that micro-ultrasound can detect significant prostate cancer with a sensitivity of 94% to 100%, which is comparable to or better than the 88% to 90% sensitivity of the more commonly used mpMRI. This suggests that micro-ultrasound is a promising tool for detecting prostate cancer effectively. ^{1 2 3 4 5}

Is micro-ultrasound safe for use in humans?

The research articles focus on the effectiveness of micro-ultrasound for detecting prostate cancer, but they do not provide specific safety data. However, micro-ultrasound is a type of imaging technology, similar to other ultrasound methods, which are generally considered safe for human use. ^{2 6 7 8 9}

How does micro-ultrasound differ from other treatments for prostate cancer detection?

Micro-ultrasound is a new imaging technology that uses high-frequency sound waves to create detailed images of the prostate, allowing for real-time visualization of suspicious lesions. It offers a comparable or superior sensitivity to the standard multiparametric MRI, is more accessible, and can be a more convenient and cost-effective option for diagnosing prostate cancer. ^{4 9 10 11 12}

Research Team

Leonard S. Marks

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 (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 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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Prostatic high resolution micro-ultrasound (MUS) imaging.] [2022]

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

Detection of Clinically Significant Index Prostate Cancer Using Micro-ultrasound: Correlation With Radical Prostatectomy. [2022]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Micro-Ultrasound: a way to bring imaging for prostate cancer back to urology. [2021]

4. United States 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. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Comparison of conventional transrectal ultrasound, magnetic resonance imaging, and micro-ultrasound for visualizing prostate cancer in an active surveillance population: A feasibility study. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Use of high-resolution micro-ultrasound to predict extraprostatic extension of prostate cancer prior to surgery: a prospective single-institutional study. [2022]

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

Diagnostic performance of microUltrasound at MRI-guided confirmatory biopsy in patients under active surveillance for low-risk prostate cancer. [2023]

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

Micro-Ultrasound-Guided vs Multiparametric Magnetic Resonance Imaging-Targeted Biopsy in the Detection of Prostate Cancer: A Systematic Review and Meta-Analysis. [2021]

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

Comparison Between Micro-Ultrasound and Multiparametric MRI Regarding the Correct Identification of Prostate Cancer Lesions. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? [2021]

12. Canada pubmed.ncbi.nlm.nih.gov

Detection of clinically significant prostate cancer by micro-ultrasound-informed systematic biopsy during MRI/micro-ultrasound fusion biopsy. [2023]