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

U

University Hospital Padova

Status

Enrolling

Conditions

Prostate Cancer Diagnosis

Treatments

Device: different needle size for prostate biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT06420115
AOP2780

Details and patient eligibility

About

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

Full 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.

Enrollment

580 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

580 participants in 2 patient groups

mpMRI target prostate biopsy with 16 gauge needle
Experimental group
Treatment:
Device: different needle size for prostate biopsy
mpMRI target prostate biopsy with 18 gauge needle
Experimental group
Treatment:
Device: different needle size for prostate biopsy

Trial contacts and locations

1

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Central trial contact

Fabio F. Zattoni, MD, PhD

Data sourced from clinicaltrials.gov

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