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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

A

Ankara Etlik City Hospital

Status

Completed

Conditions

Prostate Adenocarcinoma
Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT06029088
I05-328-23

Details and patient eligibility

About

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.

Enrollment

616 patients

Sex

Male

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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