RecruitingNot ApplicableNCT06517901

Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Sponsor

Albany Medical College

Enrollment

1,306 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Diagnosis

Summary

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) or 2. Visually estimated MRI-informed (cognitive fusion) technique To 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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

Men undergoing prostate biopsy (either transrectal or transperineal) for suspected prostate cancer as part of their regular medical care
Must be eligible to undergo both prostate biopsy procedure (cognitive or fusion)
Men undergoing their first prostate biopsy procedure or with no previous prostate biopsy within 3 years
Pre-biopsy mp-MRI of prostate with one or more lesions classified as PIRADS 3-5
Largest dimension of any lesion on mp-MRI to be ≤ 2 cm
Prostate-specific antigen level ≤ 20 ng/mL and/or abnormal digital rectal examination

Exclusion Criteria4

mp-MRI detected lesions that are \> 2 cm
History of prostate biopsy within 3 years
Previous diagnosis of prostate cancer
Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities as per treating physician)

Interventions

PROCEDURESoftware fusion prostate biopsy

Software fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).

PROCEDURECognitive fusion prostate biopsy

Cognitive fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using visual estimation and/or measurements of lesion. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).