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A prospective cohort clinical study on the clinical value of prostate biopsy patterns based on PI-RADS scoring

A prospective cohort clinical study on the clinical value of prostate biopsy patterns based on PI-RADS scoring

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114101
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-12-25
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

Prostate Cancer

Interventions

Group 4 (PI-RADS >=4 points and tPSA <=10 ng/ml):None
Group 1 (PI-RADS = 3 points, abnormal tPSA, fPSA/tPSA, or PSAD):None
Group 2 (PI-RADS = 4 points and tPSA > 10 ng/ml):None
Group 3 (PI-RADS = 4 points and tPSA > 10 ng/ml):None

Sponsors

Shenzhen Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Male, aged 50-80 years; 2)Suspicious lesions were found on mp MRI, with at least one lesion having a PI-RADS score =3, and abnormal tPSA and/or PSAD or f/t PSA; 3)Good compliance, able to communicate well with researchers; 4)Voluntarily participate in the study and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1)Patients diagnosed with prostate cancer or acute prostatitis; 2)During the acute infection phase or in cases of urinary tract infection, researchers believe that a routine urine test has clinical significance; 3)Those who have undergone a prostate biopsy within one month; 4)Previously underwent prostate surgery, or received androgen deprivation therapy, radiotherapy, and chemotherapy; 5)In the decompensated stage of heart failure; 6)People with diseases that cause severe bleeding tendencies or those who take anticoagulants long-term and cannot stop taking them; 7)Severe internal hemorrhoids, external hemorrhoids, perianal or rectal lesions; 8)Patients with severe osteoarticular diseases who cannot assume the lithotomy position; 9)A hypertensive crisis; 10)Unable to undergo anesthesia; 11)Individuals with mental illness or mental disorders who cannot understand the informed consent form; 12)People who use electronic devices such as implanted pacemakers, cochlear implants, and nerve stimulators; 13)Other surgical contraindications, or individuals deemed unsuitable to participate in the trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Positive rate of prostate biopsy;

Secondary

MeasureTime frame
Positive rates of prostate biopsy at different stratifications;

Countries

China

Contacts

Public ContactWu Tao

Shenzhen Hospital of Southern Medical University

Doctorwu1987@163.com+86 138 2645 4576

Outcome results

None listed

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