KCT0007092
Not yet recruiting
未知
The Effectiveness and Safety probability of Magnetic Resonance/Ultrasound Image Fusion System guided Prostate Target Biopsy in Biopsy naive Men with Elevated Prostate specific Antigen: A Multicenter, Prospective study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Seoul National University Hospital
- Enrollment
- 390
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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