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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053131
Enrollment
Unknown
Registered
2021-11-12
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

Prostate cancer

Interventions

Gold Standard:Prostate biopsy.
Index test:PHI&#32
combined&#32
with&#32
PI-RADS&#32
score&#32
for&#32
diagnosis&#32
of&#32
significant&#32
cancer.

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Male patients aged>= 50 years; 2.Patients who can perform multi-parameter MRI examination; 3.Hybritech PSA 4.0~10.0 ng/mL; 4.Patients who meet the indications of prostate puncture and can perform standardized prostate puncture (perineal or transrectal can be used); 5.Needle biopsy can be confirmed.

Exclusion criteria

Exclusion criteria: 1.Have a history of prostate cancer; 2.Use of drugs that affect PSA before blood sampling, such as finasteride; blood shall be collected at least 2 weeks after stopping the drug; 3.Before blood sampling, performed operations that affect PSA, such as prostate massage; blood is collected at least 3 days later.

Design outcomes

Primary

MeasureTime frame
Prostate imaging reporting and data system;Prostate health Index;Pathological results;Sensitivity and specificity;

Countries

China

Contacts

Public ContactChen Shouzhen

Qilu Hospital of Shandong University

jxin19981020@163.com+86 18560089085

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026