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A Prospective, Single-center Research for Instructing prostate biopsy with combining prostate health index (phi) and ADC values

A Prospective, Single-center Research for Instructing prostate biopsy with combining prostate health index (phi) and ADC values

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200066455
Enrollment
Unknown
Registered
2022-12-06
Start date
2022-12-15
Completion date
Unknown
Last updated
2023-05-15

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 specimens
Index test:Prostate health index(PHI),apparent diffusion coefficient value

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1)Sign written informed consent; 2)Male patients aged 40 to 90 years; 3);Patients who underwent mpMRI; 4)Patients with PSA4~20ng/ml; 5)patients who met the indications for prostate puncture and were able to undergo ultrasound-guided trans-perineal prostate puncture biopsy (systemic puncture+targeted puncture).

Exclusion criteria

Exclusion criteria: 1)Patients whose PSA is not in the range of 4-20ng/ml; 2)Patients with acute prostatitis or untreated urinary tract infection; 3) patients who were treated with 5-alpha reductase inhibitors; 3) patients who underwent transurethral resection of the prostate or prostate biopsy previously; 4)Prostate mpMRI was not performed in our hospital.

Design outcomes

Primary

MeasureTime frame
Prostate health index;apparent diffusion coefficient value;Sensitivity;Specificity;—

Countries

China

Contacts

Public ContactWang Yong

The Second Hospital of Tianjin Medical University

wy@tmu.edu.cn+86 15122286696

Outcome results

None listed

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