1306 Participants Needed

Biopsy Techniques for Prostate Cancer Detection

(FOCUS-PC Trial)

BM
Overseen ByBadar M Mian, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Albany Medical College
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Cognitive fusion prostate biopsy, Software fusion prostate biopsy for prostate cancer detection?

Research shows that both cognitive and software fusion biopsy techniques are effective in detecting significant prostate cancer, with studies comparing them to standard biopsy methods and finding them to be more accurate in identifying clinically relevant cases.12345

Is cognitive fusion prostate biopsy safe for humans?

Cognitive fusion prostate biopsy is considered a safe alternative to standard systematic biopsy, with studies showing it is easy to perform and improves cancer detection accuracy.12678

How does cognitive and software fusion prostate biopsy differ from other treatments for prostate cancer detection?

Cognitive and software fusion prostate biopsies are unique because they combine ultrasound and MRI images to better target suspicious areas in the prostate, improving the accuracy of cancer detection compared to standard biopsy methods. Cognitive fusion is a simpler and more cost-effective alternative to computer-assisted fusion, making it more accessible while still enhancing the detection of clinically significant prostate cancer.12369

What is the purpose of this trial?

The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques:1. Software-based fusion of MRI and ultrasound images (software fusion) or2. Visually estimated MRI-informed (cognitive fusion) techniqueTo date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.

Research Team

BM

Badar M Mian, MD

Principal Investigator

Albany Medical College

Eligibility Criteria

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.
See 3 more

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)
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive fusion biopyExperimental Treatment1 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 biopsyActive Control1 Intervention
Software fusion biopsy: Biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials
96
Recruited
12,700+

References

1.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Fusion biopsy of the prostate]. [2019]
Cognitive zonal fusion biopsy of the prostate: Original technique between target and saturation. [2022]
Transperineal US-MRI Fusion-Guided Biopsy for the Detection of Clinical Significant Prostate Cancer: A Systematic Review and Meta-Analysis Comparing Cognitive and Software-Assisted Technique. [2023]
Pathological Accuracy in Prostate Cancer: Single-Center Outcomes of 3 Different Magnetic Resonance Imaging-Targeted Biopsy Techniques and Random Systematic Biopsy. [2022]
Targeted prostate biopsy using a cognitive fusion of multiparametric magnetic resonance imaging and transrectal ultrasound in patients with previously negative systematic biopsies and non-suspicious digital rectal exam. [2020]
Transperineal Prostate Biopsy Targeted by Magnetic Resonance Imaging Cognitive Fusion. [2023]
The cognitive fusion prostate biopsy using a smart phone in the diagnosis of prostate cancer. [2022]
Target detection: magnetic resonance imaging-ultrasound fusion-guided prostate biopsy. [2022]
Surface-projection-based transperineal cognitive fusion targeted biopsy of the prostate: an original technique with a good cancer detection rate. [2020]
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