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

NCT06029088 | Completed

• 1 other identifier: I05-328-23
• Study Type: observational
• Target: 616
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

Prostate cancer; Risk-adapted strategy; Magnetic resonance imaging; Prostate-specific antigen density; PIRADS

Outcome Measures

Primary Outcomes (1)

• 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

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Because prostate cancer is a male-specific disease
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

tertiary care clinic

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara University School of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 8, 2023
• Study Start: January 12, 2023
• Primary Completion: May 21, 2023
• Study Completion: June 16, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

TU (1)