Evaluation of Transrectal Perilesional Biopsy in Diagnosis of Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT06482658
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 340
Inclusion Criteria:<br><br> - The age of the patient is between 45 and 85.<br><br> - No previous biopsy,<br><br> - Patients with single suspicious lesion, complete multiparametric magnetic resonance<br> imaging (mpMRI) data, qualified image quality control, suspicious lesions, and<br> Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of = 4.<br><br> - Patients were in accordance with the indication of prostate biopsy, including<br> patients with suspicious prostate nodes found by digital rectal examination (DRE),<br> the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total<br> prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA<br> ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.<br><br> - The prostate biopsy pathological results were complete. The time interval between<br> prostate biopsy and prostate mpMRI examination should not exceed one month.<br><br> - Patients with complete clinical information.<br><br>Exclusion Criteria:<br><br> - The mpMRI data was unqualified or incomplete.<br><br> - Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or<br> surgery treatment before prostate mpMRI examination or prostate biopsy.<br><br> - Patients with previous biopsy.<br><br> - Patients with PI-RADS V2.1 of < 4.<br><br> - Patients were not in accordance with the indication of prostate biopsy.<br><br> - The patient could not cooperate to complete the prostate biopsy.<br><br> - The patients or their family members refused to participate in this study.<br><br> - Patients with incomplete clinical information.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The clinically significant prostate cancer (csPCa) detection rate for PB/RSB and TB+SB
- Secondary Outcome Measures
Name Time Method The overall complication rate;The self-reported quality of life after the prostate biopsy;The operation time of prostate biopsy;The PCa detection rate;The clinically insignificant PCa detection rate;The Gleason score (GS) of the biopsy sample;The Gleason score (GS) of radical prostatectomy (RP) specimens