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

Seoul National University Hospital0 个研究点目标入组 390 人开始时间: 待定最近更新: 2022年4月4日

试验速览

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•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

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