Biopsy Techniques for Prostate Cancer Detection

(FOCUS-PC Trial)

Recruiting at 3 trial locations

Overseen By Badar M Mian, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Albany Medical College

Disqualifiers: Prostate cancer, Biopsy last 3 years, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1306 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which biopsy method better detects significant prostate cancer. Researchers are comparing two techniques: software fusion prostate biopsy, which combines MRI and ultrasound images with software, and cognitive fusion prostate biopsy, which relies on a doctor’s visual skills to target the biopsy. Men with suspicious areas on a prostate MRI and scheduled for a biopsy might be suitable candidates. Participants should not have had a prostate biopsy in the past three years and must have specific MRI findings. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance future prostate cancer detection methods.

Do I need to stop my current medications for the trial?

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

What prior data suggests that these biopsy techniques are safe for prostate cancer detection?

Research has shown that both cognitive fusion and software fusion biopsies for detecting prostate cancer are generally safe.

For cognitive fusion biopsies, studies have found them to be practical and safe. One study reported that using cognitive fusion in transperineal prostate biopsies (a method accessing the prostate through the skin between the scrotum and anus) caused no significant harm to patients.

On the software fusion side, research indicates a good safety record. A review found that software fusion devices are safe and effective for prostate biopsies. Additionally, transperineal biopsies using software fusion have demonstrated a lower risk of infection and bleeding.

Both cognitive and software fusion biopsies have been well-tolerated by patients and have not been linked to serious side effects. This suggests that both methods are safe options for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these biopsy techniques for prostate cancer detection because they offer innovative ways to improve accuracy. Unlike traditional prostate biopsies, which often rely on random sampling, software fusion biopsy uses advanced imaging platforms, like UroNav, to precisely target and sample MRI-detected lesions. This can potentially increase the detection rate of significant cancers. On the other hand, cognitive fusion biopsy relies on the skill and experience of the physician to visually estimate and pinpoint lesions, potentially offering a more cost-effective and accessible option while still improving accuracy over standard methods. Both techniques aim to enhance diagnostic precision, reducing unnecessary procedures and improving patient outcomes.

What evidence suggests that these biopsy techniques are effective for prostate cancer detection?

This trial will compare cognitive fusion biopsy with software fusion biopsy for prostate cancer detection. Studies have shown that both methods effectively find important prostate cancer. Research indicates that software fusion biopsies detect significant cancer in about 28.6% of cases. Cognitive fusion biopsies achieve similar success rates, potentially using fewer samples. Some studies suggest that cognitive fusion might result in fewer "no cancer" findings, indicating it could be more precise in some cases. Overall, both methods show promise in detecting important cancer, and this study aims to determine which one might be superior. ^{1 4 5 6 7}

Who Is on the Research Team?

Badar M Mian, MD

Principal Investigator

Albany Medical College

Are You a Good Fit for This Trial?

Men who may have prostate cancer, with suspicious lesions seen on MRI scans and PSA levels at or below 20 ng/mL. They should not have had a prostate biopsy in the last three years and are about to undergo their first one.

Inclusion Criteria

I am eligible for a prostate biopsy.

My MRI showed at least one area of concern in my prostate.

I am a man having my first prostate biopsy or haven't had one in the last 3 years.

Exclusion Criteria

History of prostate biopsy within 3 years

I have been diagnosed with prostate cancer before.

Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities 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 undergo MRI-targeted prostate biopsy using either software-based fusion or cognitive fusion technique

1 day

1 visit (in-person)

Follow-up

Participants are monitored for detection rates of clinically significant prostate cancer

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive fusion prostate biopsy
• Software fusion prostate biopsy

Trial Overview

This study compares two methods of targeting biopsies for suspected prostate cancer: software fusion combines MRI with ultrasound images, while cognitive fusion uses visual estimation based on MRI results.

How Is the Trial Designed?

Group I: Cognitive fusion biopy Experimental Treatment 1 Intervention

Cognitive fusion biopsy: Biopsy of the MRI-detected lesion using visual estimation and/or measurements to identify landmarks and lesions.

Group II: Software fusion biopsy Active Control 1 Intervention

Software fusion biopsy: Biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar.

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39367754/

MRI software and cognitive fusion biopsies in people with ...

Compared with cognitive fusion, patients receiving a SF biopsy may have: (1) a lower probability of having a 'no cancer' result, (2) similar probability of ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1078143923003587

Performance of cognitive vs. image-guided fusion biopsy ...

The aim of our study is to compare the rates of detection of cs-CaP and overall CaP by CFB and IGFB in a multiethnic community.

3.

journals.lww.com

journals.lww.com/ursc/fulltext/2025/06000/predictors_for_clinically_significant_prostate.8.aspx

Predictors for clinically significant prostate cancer detection

The study compared TSAFB using the KOELIS Trinity MRI TPUS Biopsy System with TCFB. The primary outcome was the detection rate of csPCa.

4.

nature.com

nature.com/articles/s41391-024-00827-x

Prostate cancer detection and complications of MRI ...

Results of fusion prostate biopsy comparing with cognitive and systematic biopsy. J Cancer Res Clin Oncol. 2023;149:15085–90. Article PubMed ...

5.

bmcmedicine.biomedcentral.com

bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03742-z

Comparison of MRI artificial intelligence-guided cognitive ...

According to previous publications, it was conservatively hypothesized that the csPCa detection rate of cTB combined with SB was 40% [4, 14].

6.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2827887

Oncological Safety of MRI-Informed Biopsy Decision ...

Findings In this cohort study involving 593 biopsy-naive men, 48% had negative MRI results, 86% of whom avoided biopsy over 3 years. After 3 ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1538472124003751

Feasibility and Safety of Transperineal Prostate Biopsy in ...

Conclusions. Transperineal prostate biopsy by cognitive fusion of magnetic resonance images and ultrasound is feasible, safe, with significant positivity rates ...