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Recruiting NCT06420115

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

No phase Interventional Prostate Cancer Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: different needle size for prostate biopsy.
Who it may be relevant to
Registry conditions: Prostate Cancer Diagnosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device different needle size for prostate biopsy
    MRI Fusion Transperineal Prostate Biopsy

Primary outcome measures

  • Total number of random and fusion-target biopsies with presence of prostate cancer [Time frame: When histological report available]
  • 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]
Secondary outcome measures (4)
  • Neoplasia/core ratio for each random and fusion-target biopsy [Time frame: When histological report available]
  • Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS) [Time frame: 30 days]
  • Number of hospitalizations at 30 and 60 days post-procedure [Time frame: 60 days from biopsy]
  • Number of intra- and perioperative complications associated with 18G and 16G needles [Time frame: 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 1 center
  • Urology Unit - Padua University Hospital — Padua

Identifiers

NCT: NCT06420115 · AOP2780

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗