Exploration of the application of prostate cancer antigen 3 (PCA3) combined with mpMRI screening in the population with PSA value ranging from 2 to 20 ng/ml

Exploration of the application of prostate cancer antigen 3 (PCA3) combined with mpMRI screening in the population with PSA value ranging from 2 to 20 ng/ml: A national multicenter prospective study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600127430

Enrollment

Unknown

Registered

2026-06-30

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-07-13

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:Taking the results of puncture biopsy as the gold standard

Index test:Blood PSA, urine PCA3, mpMRI individual and combined detection

Eligibility

Sex/Gender

Male

Age

45 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Male patients aged 45 years or older; 2.Serum tPSA level within the range of 2–20 ng/mL, and scheduled for mpMRI examination;

Exclusion criteria

Exclusion criteria: 1. Those who have received androgen deprivation therapy or other drug treatments that affect PSA levels within one year; 2. Patients who have been definitively diagnosed with prostate cancer or have undergone radical prostatectomy/radiotherapy; 3. Individuals who have undergone extensive prostate surgeries (such as transurethral prostate resection) and whose PSA and PCA3 levels may be affected; 4. Other situations that the researchers consider unsuitable for inclusion in the study.

Design outcomes

Primary

Measure	Time frame
The efficacy indicators of blood PSA, urine PCA3, and mpMRI, when used individually or in combination, for differentiating clinically significant prostate cancer (csPCa) from non-clinically significan;The detection rates of prostate cancer by individual and combined detection of blood PSA, urine PCA3, and mpMRI;Diagnostic efficacy evaluation (sensitivity, specificity, predictive value and accuracy);	—

Measure

Time frame

The efficacy indicators of blood PSA, urine PCA3, and mpMRI, when used individually or in combination, for differentiating clinically significant prostate cancer (csPCa) from non-clinically significan;The detection rates of prostate cancer by individual and combined detection of blood PSA, urine PCA3, and mpMRI;Diagnostic efficacy evaluation (sensitivity, specificity, predictive value and accuracy);

—

Secondary

Measure	Time frame
Urine PCA3 testing combined with PSA-PCA3-mpMRI and the reduction of biopsy puncture paths through the puncture route selection can decrease the rate of prostate biopsy punctures and the detection rat;The incidence and severity of adverse reactions;Complications related to prostate biopsy;	—

Countries

China

Contacts

Public ContactLiu Ming

Beijing Hospital

liuming19731029@163.com+86 10 85136271

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026