AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital Padova
- Enrollment
- 580
- Locations
- 1
- Primary Endpoint
- Total number of random and fusion-target biopsies with presence of prostate cancer
Study Overview
Brief Summary
Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer
Detailed Description
To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination);
- •Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy.
Exclusion Criteria
- •Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
- •Previous radiotherapy to the prostate for neoplasia.
Arms & Interventions
mpMRI target prostate biopsy with 18 gauge needle
Intervention: different needle size for prostate biopsy (Device)
mpMRI target prostate biopsy with 16 gauge needle
Intervention: different needle size for prostate biopsy (Device)
Outcomes
Primary Outcomes
Total number of random and fusion-target biopsies with presence of prostate cancer
Time Frame: When histological report available
The primary outcome measure involves assessing the total number of biopsies, including both random and fusion-targeted approaches, that reveal the presence of prostate cancer.
Number of random and fusion-target biopsies with clinically significant prostate cancer (defined as International Society of Urological Pathology >=2)
Time Frame: When histological report available
The primary outcome measure focuses on the number and the detection rates of random and fusion-target biopsies revealing clinically significant prostate cancer aof clinically significant prostate cancer (defined as ISUP \>=2) between 16-gauge and 18-gauge biopsy needles.
Secondary Outcomes
- Neoplasia/core ratio for each random and fusion-target biopsy(When histological report available)
- Number of hospitalizations at 30 and 60 days post-procedure(60 days from biopsy)
- Number of intra- and perioperative complications associated with 18G and 16G needles(30 days)
- Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)(30 days)
Investigators
FABIO ZATTONI
MD, Phd
University Hospital Padova