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Trial Title:
Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
NCT ID:
NCT06420115
Condition:
Prostate Cancer Diagnosis
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
pca
needle
16 gauge
18 gauge
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
different needle size for prostate biopsy
Description:
MRI Fusion Transperineal Prostate Biopsy
Arm group label:
mpMRI target prostate biopsy with 16 gauge needle
Arm group label:
mpMRI target prostate biopsy with 18 gauge needle
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Urology Unit - Padua University Hospital
Address:
City:
Padua
Zip:
35100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Zattoni, MD, PhD
Email:
fabio.zattoni@unipd.it
Contact backup:
Last name:
Filippo Carletti, MD
Email:
filippo.carletti@aopd.veneto.it
Start date:
June 1, 2024
Completion date:
May 30, 2025
Lead sponsor:
Agency:
University Hospital Padova
Agency class:
Other
Source:
University Hospital Padova
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06420115
