None listed
Conditions
Interventions
None listed
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant prostate cancer diagnosis rates | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactHyeong Dong Yuk
Seoul National University Hospital
Outcome results
None listed