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Clinical study of the effectiveness of p2PSA in the diagnosis of prostate cancer in patients with PSA gray area

Clinical study of the effectiveness of p2PSA in the diagnosis of prostate cancer in patients with PSA gray area

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079469
Enrollment
Unknown
Registered
2024-01-04
Start date
2023-06-12
Completion date
Unknown
Last updated
2024-01-08

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:The gold standard for diagnosing prostate cancer is prostate system biopsy in this project.
Index test:Index test:p2PSA, %p2PSA, PHI

Sponsors

The Second Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Male. 2.At least 50 years old. 3.Serum PSA test was performed in the Second Affiliated Hospital of Kunming Medical University, the test results were 4-10ng/ml, and no catheterization, prostate massage, urethra or perineal trauma was performed before PSA test. Patients with urinary catheterization, prostate massage, or urethral or perineal trauma before PSA screening were admitted to the study group if serum PSA was 4-10ng/ml 3 months later. 4.The digital rectal examination was negative ( the digital rectal examination did not reach the hard or hard nodules of the prostate. 5.Ultrasound and MRI revealed no suspicious lesions. 6.The blood clotting function is normal. If the patient takes aspirin, clopidogrel and other anticoagulants for a long time, the drugs should be stopped for at least 1 week. 7.Volunteer to participate in this clinical trial, understand the study procedures and have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Serum PSA10ng/ml. 2.After electroprostatectomy. 3.After radical surgery for prostate cancer. 4.The patient had obvious coagulation dysfunction. 5.Acute prostatitis or acute inflammation of the prostate piercing area. 6.Prostate biopsy is not possible for anal and rectal lesions(such as low tumor). 7.Lower limb dyskinesia can not match puncture position. 8.Other serious systemic diseases such as poorly controlled high blood pressure, severe diabetes, neurological or mental illness, etc.

Design outcomes

Primary

MeasureTime frame
Prostate-specific antigen isomer 2(PSA);

Secondary

MeasureTime frame
%pProstate-specific antigen isomer 2(%PSA);prostate health index(PHI);sensitivity;specificity;

Countries

China

Contacts

Public ContactDaoqi Wang

The Second Affiliated Hospital of Kunming Medical University

daoqi5050@outlook.com+86 135 2917 4480

Outcome results

None listed

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