Evaluation of the efficacy of the detection of the significant cancer and the safety in MRI-TRUS fusion image-guided prostate biopsy: multi-institutional study in Japa
Not Applicable
- Conditions
- prostate cancer suspected
- Registration Number
- JPRN-UMIN000042397
- Lead Sponsor
- Tokai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
1. the patiens who have fatal disease 2. the patiens who are suspected as having progressive prostate cancer 3. the patiens who are suspected as having progressive prostate cancer with digital rectal examination 4. the patiens who are suspected as having progressive prostate cancer on MRI 5. the patiens who have abnormal blood coagulation 6. the patients who have the allergy for the anesthesia 7. the patients who were regarded as being inappropriate 8. the person with less than 20 years olds
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection of the significant cancer in the patients and biopsy cores of systematic and target biopsies
- Secondary Outcome Measures
Name Time Method a) cancer core length, cancer core percentage, and Gleason score in the biopsy cores of systematic and target biopsies b) the relation between the PI-RADS category, cancer core length, cancer core percentage, and Gleason score in the biopsy cores of target biopsies c) examination time c-1) time for segmentaion c-2) time for anesthesia c-3) time for the entire examination time for target biopsy time for systematic biopsy c-4) operating room usage time d) extension of hospital stay, and the reason e) emergency outpatient consultation, and the reason f) analysis using whole gland specimens for the detecion of significant cancer in systematic and target biopsy Safety Pain in the biopsy site, bleeding from the biopsy site, infection in the biopsy site, urinary tract infection, macroscopic hematuria, fever, urinary retension, and other (Grades of the complications would be evaluated with Common Terminology Criteria for Adverse Events (CTCAE) v5.0)