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Diagnostic value of detection of PCA3 and PSA gene expression in morning urine (fluorescence PCR) for people suspected of prostate cancer

Diagnostic value of detection of PCA3 and PSA gene expression in morning urine (fluorescence PCR) for people suspected of prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114093
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-12
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

prostatic cancer

Interventions

Index test:Detection of PCA3 and PSA gene expression in morning urine (fluorescence PCR)

Sponsors

Beijing Shijitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 45 years and above who meet any of the following requirements for a prostate biopsy: 1. DRE found suspicious prostate nodules, any PSA value; 2. suspicious lesions were found by transrectal ultrasound or MRI, with any PSA value; 3. PSA>10ng/ml; 4. PSA4~10ng/ml, the ratio of free PSA to total PSA is suspicious or the PSA density value is suspicious.

Exclusion criteria

Exclusion criteria: 1. Patients who have not completed prostate puncture examination and cannot be diagnosed; 2. Subjects who have been treated with antiandrogen drugs within one year; 3. Subjects with previous history of prostate cancer or prostate cancer surgery; 4. The researcher thinks it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;

Secondary

MeasureTime frame
PCA3 gene;PSA gene;

Countries

China

Contacts

Public ContactLiu Na

Beijing Shijitan Hospital, Capital Medical University

578980787@qq.com+86 138 1161 0844

Outcome results

None listed

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