Efficacy and Cost-effectiveness of MRI to select men who need prostate biopsy
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0005219
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 234
Patients who have clinically suspected prostate cancer and are planning a biopsy (at least one of the criteria below is satisfied)
1. Serum PSA> 3ng / ml and <= 30ng / ml
2. Suspected nodule in digital rectal examination
3. Abnormal lesions in transrectal ultrasonography
Patients scheduled to undergo 1.5T or 3.0T multiparametric prostate MRI prior to biopsy
-Patients with previous histologically diagnosed prostate cancer
-Those who are contraindicated in MRI
-Those who are contraindicated for prostate biopsy
-Those who are expected to have artifacts on MRI images due to previous hip replacement surgery, pelvic surgery, etc.
-Hemorrhagic tendency and anticoagulant / antiplatelet treatment
-Acute urinary tract infection
-People with hemorrhoids / anal fissure / anal fistulas
-Those who have a history of allergies to lidocaine
-Those who are judged to be inappropriate to participate in clinical trials
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinically significant prostate cancer diagnosis rates
- Secondary Outcome Measures
Name Time Method All prostate cancer diagnosis rates;All and clinically significant prostate cancer diagnosis rates of PI-RADS 3-5 lesions;Rates of MR / US target biopsy not performed due to no abnormal lesions in PI-RADS;EQ-5D-5L utility value (baseline, 2 weeks);IPSS score (baseline, 2 weeks);Rates f prostate cancer treatment;Pathology results in patients undergoing radical prostatectomy (within 90 days of biopsy);Medical costs by prostate cancer diagnosis