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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179707
• Other study ID #: CSZ01
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: January 2022
• Source: Qilu Hospital of Shandong University
• Contact: Shouzhen Chen, Dr.
• Phone: 18560089085
• Email: chensz[@]mail.sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 936
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
China	Qilu hospital	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Zibo Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Health Index	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,	1 year
Primary	PI-RADS score	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.	1 year
Primary	Prostate biospy pathology	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	1 year