Clinical trial for Prostate Cancer
Official title Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer
ClinicalTrials.gov ID: NCT06517901
What this study is testing
- What it's testing
- The study aims to find out whether the software‑fusion or the cognitive MRI‑ultrasound guided biopsy detects more clinically important prostate cancer.
- Who it's for
- Men who have a suspicious area on a multi‑parametric MRI scan of the prostate.
- What's involved
- Participants will be randomly assigned to have a prostate biopsy using either the software‑fusion technique or the cognitive technique, followed by standard testing to assess the results.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Burlington, Massachusetts, United States
- Albany, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Burlington, Massachusetts, United States; Albany, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.