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

NCT06420115 | Recruiting

• 1 other identifier: AOP2780
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer Diagnosis

Keywords

pca; needle; 16 gauge; 18 gauge

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Neoplasia/core ratio for each random and fusion-target biopsy

  When histological report available

• Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)

  30 days

• 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

Study Arms (2)

mpMRI target prostate biopsy with 16 gauge needle

EXPERIMENTAL

Device: different needle size for prostate biopsy

mpMRI target prostate biopsy with 18 gauge needle

EXPERIMENTAL

Device: different needle size for prostate biopsy

Interventions

different needle size for prostate biopsy DEVICE

MRI Fusion Transperineal Prostate Biopsy

mpMRI target prostate biopsy with 16 gauge needle; mpMRI target prostate biopsy with 18 gauge needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (1)

Urology Unit - Padua University Hospital

Padua, Italy, 35100, Italy

RECRUITING

MeSH Terms

Conditions

Choanal Atresia, Posterior

Study Officials

• Fabio Zattoni, MD, PhD

  Department of Surgery, Oncology and Gastroenterology, Urology Clinic, University of Padua, Padova,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio F. Zattoni, MD, PhD

CONTACT

0498212730; fabio.zattoni@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Phd

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 17, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)