Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial
- Conditions
- Prostate Cancer
- Registration Number
- NCT06362291
- 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> 1. The age of the patient is between 45 and 85.<br><br> 2. Patients with complete multiparametric magnetic resonance imaging (mpMRI) data of<br> Peking University First Hospital, qualified image quality control, suspicious<br> lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1)<br> of = 3.<br><br> 3. 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> 4. Patients were in accordance with the indication of repeated prostate biopsy<br> (patients with atypical acinar hyperplasia or high-grade intraepithelial neoplasia,<br> especially when the pathological results of multi-needle puncture were as above;<br> re-examination of PSA > 10 ng/ml; re-examination of PSA 4~10ng/ml, abnormal f/tPSA,<br> abnormal PSAD, abnormal DRE, or imaging abnormalities; for patients with the results<br> of re-examination of PSA 4~10ng/ml and with close follow-up, PSA for 2 consecutive<br> years > 10ng/ml or PSA volume > 0.75/ml/ years). The time interval between the two<br> prostate biopsies should be longer than three months.<br><br> 5. The targeted prostate biopsy pathological results of above lesions were complete.<br> The time interval between targeted prostate biopsy and prostate mpMRI examination<br> should not exceed one month.<br><br> 6. Patients with complete clinical information.<br><br>Exclusion Criteria:<br><br> 1. The mpMRI data was unqualified or incomplete.<br><br> 2. Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or<br> surgery treatment before prostate mpMRI examination or prostate biopsy.<br><br> 3. The mpMRI of Peking University First Hospital did not find suspicious prostate<br> lesions.<br><br> 4. Patients were not in accordance with the indication of prostate biopsy or were not<br> received systematic biopsy combined with targeted biopsy.<br><br> 5. The patient could not cooperate to complete the systematic biopsy combined with<br> targeted biopsy. The patients or their family members refused to participate in this<br> study.<br><br> 6. 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 targeted biopsy (TB) and TB combined with systematic biopsy (SB)
- Secondary Outcome Measures
Name Time Method The PCa detection rate;The Gleason score (GS) of the biopsy sample;The GS of radical prostatectomy (RP) specimens