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

• Conditions: Prostate Cancer

• Registration Number: NCT05179707
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Study Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-16
• Status Verified: 2022-01
• Study First Posted: 2022-01-05
• Study Start: 2022-02-01
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 936

Inclusion Criteria

• Patients with suspected prostate cancer
• Patients can perform standardized prostate biopsy

Exclusion Criteria

• Have a history of prostate cancer
• Use of drugs that affect PSA before blood sampling

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prostate Health Index	1 year	PHI is a simple, FDA-approved blood test that helps determine the probability of detecting prostate cancer with a biopsy. This test uses an algorithm to assess total PSA, free PSA, and p2PSA,
PI-RADS score	1 year	In PI-RADS, based on the comprehensive manifestations of prostate T2WI, DWI and DCE, a scoring method is given for the possibility of clinically significant prostate cancer. Specifically: 1 point: very low, extremely unlikely to exist; 2 points: low, impossible to exist; 3 points: moderate, suspicious existence; 4 points: high, may exist; 5 points: very high, extremely likely to exist.
Prostate biospy pathology	1 year	The pathological results of prostate puncture are used as the gold standard for the diagnosis of prostate cancer, indicating whether the patient is really suffering from prostate cancer

Trial Locations

Locations (1)

Qilu hospital; 🇨🇳 Jinan, Shandong, China