Micro-ultrasound Imaging for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: MRI contraindications, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging method, transperineal micro-ultrasound, can better detect prostate cancer during a biopsy. Traditionally, a probe guides the biopsy rectally, but this trial places a probe on the skin between the scrotum and anus for a clearer view. This technique might identify minor changes in the prostate that other methods miss. Men scheduled for a prostate biopsy who have had an MRI beforehand might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance prostate cancer detection methods.

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's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that transperineal micro-ultrasound is generally easy for patients to handle. Studies have found that it detects significant prostate cancer as effectively as other methods. This indicates it is both effective and safe for identifying prostate cancer.

Although these studies don't provide specific details about side effects, the ongoing research without major safety concerns suggests it is likely safe. The "Not Applicable" trial phase typically indicates the technique is already considered safe and is being tested in a new way. This supports the expectation that transperineal micro-ultrasound will be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transperineal micro-ultrasound imaging for prostate cancer because it offers a more precise and less invasive way to visualize the prostate compared to traditional imaging methods like standard MRI or transrectal ultrasound. This technique involves using high-resolution ultrasound directly through the perineum, potentially providing clearer images and better guidance during prostate biopsies. By improving the accuracy of biopsies, this method may lead to earlier and more accurate detection of prostate cancer, which is crucial for effective treatment.

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

Research has shown that transperineal micro-ultrasound, which participants in this trial will undergo, can detect prostate cancer more effectively than traditional methods. One study found that this biopsy method identified significant prostate cancer 5% more often. It uses higher frequency sound waves to produce clearer images, aiding doctors in spotting small changes in the prostate. Micro-ultrasound achieves similar success rates in detecting cancer as other advanced imaging methods like MRI, suggesting it could be a powerful tool for earlier and more accurate prostate cancer detection. ^{3 5 6 7 8}

Who Is on the Research Team?

Khurshid A Guru

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for men who are suspected of having prostate cancer and require a biopsy. It's exploring if transperineal micro-ultrasound, which uses higher frequency sound waves than standard ultrasound, can better detect cancer during the procedure.

Inclusion Criteria

I am a man aged 18 or older.

I am a man scheduled for a prostate biopsy and have had a prebiopsy MRI.

I understand this study is experimental and have signed the consent form.

Exclusion Criteria

Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 2 months

1 visit (in-person)

Imaging and Biopsy

Participants undergo transperineal micro-ultrasound imaging followed by transrectal micro-ultrasound imaging during standard of care prostate biopsy

Single session

1 visit (in-person)

Follow-up

Participants are monitored for the quality of imaging and successful generation of PRIMUS score

Up to 7 months

What Are the Treatments Tested in This Trial?

Interventions

• Transperineal Micro-ultrasound

Trial Overview The study compares traditional transrectal ultrasound-guided biopsies with a new method called transperineal micro-ultrasound. This new technique may provide clearer images due to its high-resolution capabilities and could improve prostate cancer detection.

How Is the Trial Designed?

Group I: Diagnostic (transperineal micro-ultrasound) Experimental Treatment 3 Interventions

Patients undergo transperineal micro-ultrasound imaging over 3 minutes followed by transrectal micro-ultrasound imaging during standard of care prostate biopsy. Patients also undergo MRI during screening.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Citations

1. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0280262

Do cancer detection rates differ between transperineal and ... TP-B has been gaining popularity due to its higher cancer detection rate in the antero-apical zones, lower sepsis rate, and lower risk of ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666168324006323

Prostate Cancer A Propensity Score–matched Comparison ... In our study, microUS-guided TRBx and MRI/TRUS-guided TPBx resulted in similar csPCa detection rates (45% vs 51%) in our PSM cohort, with no significant ...

4. 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 study results from TRANSLATE were presented and suggested that transperineal biopsy offered a 5% higher detection rate for significant ...

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

Micro-Ultrasound in the Detection of Clinically Significant ... Results: Micro-US consistently demonstrated non-inferiority to mpMRI for csPCa detection across retrospective studies, prospective cohorts, and meta-analyses.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11417145/

A Propensity Score–matched Comparison of Micro- ... Transrectal biopsy guided by micro-ultrasound alone provides similar detection rates for clinically significant prostate cancer (csPCa) to transperineal biopsy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666168324004944

Inter-reader Agreement for Prostate Cancer Detection ... PPA was 33% (95% CI 25–42%). The mean patient-level sensitivity for GG ≥2 cancer was 0.66 ± 0.05 overall and 0.87 ± 0.09 when cases with anterior lesions were ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05826470

Study Details | NCT05826470 | Investigator Initiated Trial to ... The primary objective of this study is to assess the safety & tolerability of a tandem approach using micro-ultrasound imaging for FLA in patients with organ ...