NCT05179707

A Research for Combination of Prostate Health Index (Phi) and mpMRI PI-RADS in the Diagnosis of Prostate Cancer

A Prospective, Multicenter Research for Combination of Prostate Health Index (Phi) and mpMRI PI-RADS in the Diagnosis of Prostate Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 936 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: —

Summary

Before prostate puncture, the patient's serum was collected for PHI detection, and multi-parameter MRI was performed to obtain the PI-RADS score. The sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically significant prostate cancer were explored.

Detailed description

This study is a multi-center prospective study. Patients who meet the indications for prostate puncture and whose PSA is in the gray area (4.0\~10.0 ng/mL) undergo standard prostate biopsy. The patient's serum was collected for PHI detection before puncture, and multi-parameter MRI was performed before puncture. To explore the sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically meaningful prostate cancer. Assess the benefit of combining PHI and mpMRI before biopsy compared with phi or mpMRI alone. Formulate clinical recommendations for PHI and mpMRI.

Conditions

• Prostate Cancer

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2022-01-05
• Last updated: 2022-10-12

Locations

1 site across 1 country: China