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Clinical Trials/NCT06029088
NCT06029088
Completed
Not Applicable

Risk-adapted Strategy Combining Magnetic Resonance Imaging and Prostate-specific Antigen Density to Individualize Biopsy Decision in Patients With PI-RADS 3 'Gray Zone' Lesions

Ankara Etlik City Hospital1 site in 1 country616 target enrollmentJanuary 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Ankara Etlik City Hospital
Enrollment
616
Locations
1
Primary Endpoint
Reducing unnecessary prostate biopsy with the combined use of magnetic resonance imaging and prostat-specific antigen density measurement
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 12, 2023
End Date
June 16, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Ankara Etlik City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Cagri Akpinar

M.D.

Ankara Etlik City Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Reducing unnecessary prostate biopsy with the combined use of magnetic resonance imaging and prostat-specific antigen density measurement

Time Frame: 2 weeks from the outpatient clinic admission

Study Sites (1)

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