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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05179707

Enrollment

936

Registered

2022-01-05

Start date

2022-02-01

Completion date

2023-10-01

Last updated

2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactShouzhen Chen, Dr.

chensz@mail.sdu.edu.cn18560089085

Outcome results