Actively Recruiting
Can Needle Size Improve Cancer Detection Rate of Transperineal MRI-Targeted Prostate Biopsy Without Affecting Side Effects?
Led by University Hospital Padova · Updated on 2025-03-25
580
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if using a larger needle size (16 gauge) during transperineal MRI-targeted prostate biopsy improves the detection of prostate cancer compared to a smaller needle size (18 gauge), without increasing side effects or complications. This study focuses on patients suspected of having prostate cancer based on elevated prostate-specific antigen levels or suspicious digital rectal exams, with at least one suspicious lesion on MRI. Participants will undergo a prostate biopsy using either a 16 gauge or 18 gauge needle guided by MRI fusion technology. This randomized study compares the diagnostic accuracy and side effect profiles of these two needle sizes. The main treatments involve device-based prostate biopsy performed through the skin between the scrotum and anus (transperineal). During the study, researchers will assess the number of biopsies detecting prostate cancer, including clinically significant cases, using histology reports. They will also monitor pain levels, hospitalizations, and complications up to 60 days after biopsy. Participants will be followed for safety and outcomes, with pain assessed via a visual scale and clinical data collected post-procedure.
CONDITIONS
Brief Title
Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical suspicion of prostate cancer based on elevated prostate specific antigen and/or suspicious digital rectal exam
- Presence of at least one suspicious prostate lesion on MRI with a Prostate Imaging-Reporting and Data System score of 3 or higher before biopsy
- Adults aged 18 years and older
You will not qualify if you...
- Patients under active surveillance or with a previous diagnosis of prostate cancer prior to biopsy
- Previous radiotherapy to the prostate for cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo an MRI fusion transperineal prostate biopsy using either a 16 gauge or 18 gauge needle as part of the study intervention.
1 biopsy procedure visit (in-person)
Duration - 30 to 60 days
Participants are monitored for pain, complications, and hospitalizations following the biopsy procedure.
Follow-up visits at 30 and 60 days post-procedure (in-person or remote)
Trial Site Locations
Total: 1 location
1
Urology Unit - Padua University Hospital
Padua, Italy, Italy, 35100
Actively Recruiting
Research Team
F
Fabio F. Zattoni, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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