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NCT Number: NCT06420115

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology Unit - Padua University Hospital

Padua, Italy, 35100

Location status: Recruiting

Location contact

Fabio Zattoni, MD, PhD

CONTACT

[email protected]

Filippo Carletti, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

different needle size for prostate biopsy

Device

MRI Fusion Transperineal Prostate Biopsy

Primary outcomes

  1. 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.

  2. 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

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

    Time frame: 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

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

    Time frame: 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.

  3. Number of hospitalizations at 30 and 60 days post-procedure

    Time frame: 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.

  4. Number of intra- and perioperative complications associated with 18G and 16G needles

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio F. Zattoni, MD, PhD

CONTACT

[email protected]

0498212730

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

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

Acronym: TARGET

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 17, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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