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

Shandong University

Status: Unknown

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05179707

CSZ01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 936 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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