The Effectiveness and Safety probability of Magnetic Resonance/Ultrasound Image Fusion System guided Prostate Target Biopsy in Patients with Suspected Prostate Cancer: A Multicenter, Prospective study
- Conditions
- Neoplasms
- Registration Number
- KCT0007092
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 390
Men over 19 and under 80
- Patients who have clinically suspected prostate cancer and planned a biopsy (at least one of the criteria below)
a. Serum PSA >3ng/ml and ?50ng/ml
b. Suspicion of a nodule on the direct upper hand test (DRE)
c. Abnormal lesions on rectal ultrasonography (TRUS)
- Patients with PI-RADS 3 or higher lesions on MRI
- Patients who can understand the contents of the consent form and voluntarily consent
- Patients previously histologically diagnosed with prostate cancer
- Those who are contraindicated in MRI
- Those who are contraindicated in prostate biopsy
- Those who are expected to have artifacts in the MRI image due to previous hip replacement surgery or pelvic surgery history
- Those who have a tendency to hemorrhage and are receiving anticoagulant/antiplatelet medication
- Acute urinary tract infection
- Those with hemorrhoids/anal fissures/anal fistula
- Those with a previous history of allergy to lidocaine
- Those who are judged to be inappropriate to participate in clinical trials in the judgment of other investigators
- Those who are participating in other research
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinically significant prostate cancer diagnosis rate (ISUP Grade group 2 or higher) between single targeted biopsy and parallel biopsy in patients with early stage prostate cancer biopsy
- Secondary Outcome Measures
Name Time Method All prostate cancer diagnoses;Clinically significant prostate cancer diagnosis rate by PI-RADS 3, 4, 5 lesion;Clinically all prostate cancer diagnosis rates by PI-RADS 3, 4, and 5 lesions;Diagnosis rate of clinically significant prostate cancer and all prostate cancers according to prostate biopsy method (transrectal vs. transperineal);Frequency of A/E within 2 weeks (± 1 week) after biopsy