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

Sponsor

Ankara Etlik City Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06029088

Collaborator

(none)

616

Enrollment

Location

5.1

Actual Duration (Months)

121

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Adenocarcinoma

Study Design

Study Type:

Observational

Actual Enrollment :

616 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 12, 2023

Actual Primary Completion Date :

May 21, 2023

Actual Study Completion Date :

Jun 16, 2023

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

Male

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