Risk-adapted Strategy Including Magnetic Resonance Imaging and Prostate-specific Antigen Density in Blood for Biopsy Decision in Patients With Lesions Suspicious for Prostate Cancer

Completed

• Conditions: Prostate Adenocarcinoma; Prostate Cancer

• Registration Number: NCT06029088
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

Recent guidelines now recommend multi parametric magnetic resonance imaging prior to biopsy for all men as an integral part of improved diagnosis of clinical significant prostate cancer. However, magnetic resonance imaging targeted biopsy is a strategy that focuses on maximizing detection of clinical significant prostate cancer, but this procedure has the disadvantage of leading to higher detection of clinically insignificant prostate cancers. One of the risk-stratifications developed to minimize the existing disadvantages and avoid unnecessary biopsy procedures is a strategy in which multi parametric magnetic resonance imaging and prostate-specific antigen density are used in combination. This is especially important in all patients with PI-RADS (Prostate Imaging Reporting and Data System) 3 lesions which are also interpreted as indeterminate mpMRI findings. Current guidelines suggest that biopsy may be omitted in some patient groups with PI-RADS 3 lesions in the risk-adapted strategy involving prostate-specific antigen density. The aim of this study was to evaluate the role of risk-adapted strategies involving prostate-specific antigen density in biopsy decision to avoid unnecessary biopsy vs the risk of missing clinical significant prostate cancer diagnosis in patients with PI-RADS 3 lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Primary Completion: 2023-05-21
• Study Completion: 2023-06-16
• Study First Submitted: 2023-08-26
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-06
• Last Update Submitted: 2023-09-06
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 616

Inclusion Criteria

• Patients who all had undergone multi parametric magnetic resonance imaging at our hospital
• Patients who all had undergone transrectal ultrasonography guided cognitive and fusion targeted biopsies

Exclusion Criteria

• Magnetic resonance imaging at exterior hospitals
• Insufficient image quality/artifacts
• Previous prostate biopsy and/or prior prostate cancer diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reducing unnecessary prostate biopsy with the combined use of magnetic resonance imaging and prostat-specific antigen density measurement	2 weeks from the outpatient clinic admission

Trial Locations

Locations (1)

Ankara University School of Medicine; 🇹🇷 Ankara, Turkey