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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-05-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prostate Cancer Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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mpMRI target prostate biopsy with 16 gauge needle

Group Type EXPERIMENTAL

different needle size for prostate biopsy

Intervention Type DEVICE

MRI Fusion Transperineal Prostate Biopsy

mpMRI target prostate biopsy with 18 gauge needle

Group Type EXPERIMENTAL

different needle size for prostate biopsy

Intervention Type DEVICE

MRI Fusion Transperineal Prostate Biopsy

Interventions

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different needle size for prostate biopsy

MRI Fusion Transperineal Prostate Biopsy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes