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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06029088
• Other study ID #: I05-328-23
• Status: Completed
• Start date: January 12, 2023
• Est. completion date: June 16, 2023

Study information

• Verified date: September 2023
• Source: Ankara Etlik City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: June 16, 2023
• Est. primary completion date: May 21, 2023
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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