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Development and Validation of a Predictive Model for Determining Clinically Significant Prostate Cancer in Men with Negative Magnetic Resonance Imaging after Transrectal Ultrasound-guided Prostate Biopsy

Development and Validation of a Predictive Model for Determining Clinically Significant Prostate Cancer in Men with Negative Magnetic Resonance Imaging after Transrectal Ultrasound-guided Prostate Biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040667
Enrollment
Unknown
Registered
2020-12-07
Start date
2020-12-07
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

prostate cancer

Interventions

csPCa:transrectal ultrasound-guided systematic prostate biopsy
without csPCa:transrectal ultrasound-guided systematic prostate biopsy

Sponsors

Department of Urology, ShengJing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The inclusion criteria were as follows: men aged > 18 years who underwent consecutive TRUS-guided systematic prostate biopsy, had negative biparametric MRI (bpMRI, score < 3 points evaluated by PI-RADS 2.0) results, negative transrectal ultrasound (no hypoechoic nodules in the peripheral zone), and negative digital rectal examination. Men with a PSA level <=30 ng/ml (to allow interpretation of results more relevant to a screening-based population) were recruited. Studies included both biopsy-na?ve men and those with a prior negative biopsy. The interval between MRI and biopsy was < 3 months.

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: patients with prior prostate cancer, surgical treatment for benign prostate hyperplasia (BPH), no MRI data due to contraindications (metal implants, etc.), evidence of acute urinary tract infections, acute prostatitis, and patients taking a 5a-reductase inhibitor or anti-androgen at the time of biopsy or during the previous 6 months.

Design outcomes

Primary

MeasureTime frame
PSAD;demographic and history datd;

Countries

China

Contacts

Public ContactSong Bai

Department of Urology, ShengJing Hospital of China Medical University

baisongcmu@163.com+86 18940255568

Outcome results

None listed

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