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

Not Applicable

Recruiting

• Conditions: Prostate Cancer Diagnosis
• Interventions: Device: different needle size for prostate biopsy

• Registration Number: NCT06420115
• Lead Sponsor: University Hospital Padova

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 Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-17
• Study Start: 2024-06-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 580

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.

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Exclusion Criteria

• Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
• Previous radiotherapy to the prostate for neoplasia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mpMRI target prostate biopsy with 16 gauge needle	different needle size for prostate biopsy	-
mpMRI target prostate biopsy with 18 gauge needle	different needle size for prostate biopsy	-

Primary Outcome Measures

Name	Time	Method
Total number of random and fusion-target biopsies with presence of prostate cancer	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)	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 Outcome Measures

Name	Time	Method
Neoplasia/core ratio for each random and fusion-target biopsy	When histological report available	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
Number of hospitalizations at 30 and 60 days post-procedure	60 days from biopsy	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.
Number of intra- and perioperative complications associated with 18G and 16G needles	30 days	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.
Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)	30 days	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.

Trial Locations

Locations (1)

Urology Unit - Padua University Hospital; 🇮🇹 Padua, Italy