Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects? (TARGET)

AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer Diagnosis
• Intervention / Treatment: Device: different needle size for prostate biopsy

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 Type: Interventional
• Enrollment (Estimated): 580
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio F. Zattoni, MD, PhD; Phone Number: 0498212730; Email: fabio.zattoni@unipd.it

Study Locations

• Italy
  • Padua, Italy, 35100
    • Recruiting
    • Urology Unit - Padua University Hospital
    • Contact: Fabio Zattoni, MD, PhD; Email: fabio.zattoni@unipd.it
    • Contact: Filippo Carletti, MD; Email: filippo.carletti@aopd.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mpMRI target prostate biopsy with 16 gauge needle	Device: different needle size for prostate biopsy; MRI Fusion Transperineal Prostate Biopsy
Experimental: mpMRI target prostate biopsy with 18 gauge needle	Device: different needle size for prostate biopsy; MRI Fusion Transperineal Prostate Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of random and fusion-target biopsies with presence of prostate cancer	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.	When histological report available
Number of random and fusion-target biopsies with clinically significant prostate cancer (defined as International Society of Urological Pathology >=2)	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.	When histological report available

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neoplasia/core ratio for each random and fusion-target biopsy	Neoplasia/core ratio, indicates the ratio of neoplastic tissue to healthy tissue within biopsy cores obtained through both 16 and 18 gauge biopsies for prostate cancer diagnosis. By analyzing this ratio, investivators seek to identify differences in diagnosis across the two different sizes	When histological report available
Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)	The validated pain questionnaire employed in this study is designed to comprehensively assess the intra- and perioperative pain (following 7 days) experienced by patients undergoing prostate biopsy procedures with 18G and 16G needles. The visual analog scales "VAS" is a standardized validated questionnaire, a horizontal line, where one end represents "1 - no pain" and the other end represents "10 - worst possible pain." Patients are asked to mark on the line the point that best represents the intensity of their pain.	30 days
Number of hospitalizations at 30 and 60 days post-procedure	By tracking the number of hospitalizations occurring at both 30 and 60 days post-procedure among patients undergoing prostate biopsy within these specific time frames, researchers seek to assess the short-term post-procedural outcomes and potential complications associated with the biopsy procedure. These hospitalization data will provide information into the safety profile and healthcare utilization patterns following prostate biopsy, aiding in the optimization of patient care and risk management strategies.	60 days from biopsy
Number of intra- and perioperative complications associated with 18G and 16G needles	Intraoperative complications refer to adverse events occurring during the biopsy procedure itself, while perioperative complications encompass those arising in the immediate post-procedural period. These complications may include but are not limited to bleeding, infection, urinary retention, and vasovagal reactions. By documenting these complications, investigators will evaluate the safety profile and potential risks associated with each needle gauge, thereby informing clinical decision-making and optimizing patient outcomes.	30 days

Collaborators and Investigators

• Sponsor: University Hospital Padova
• Investigators: Principal Investigator: Fabio Zattoni, MD, PhD, Department of Surgery, Oncology and Gastroenterology, Urology Clinic, University of Padua, Padova,

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: needle; pca; 16 gauge; 18 gauge
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: AOP2780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only if requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No