prostate cancer suspected
Conditions
Interventions
None listed
Sponsors
Tokai University
Kanazawa Medical University, Saiseikai Kawaguchi General Hospital, Nagoya City University, The Jikei University School of Medicine, Okayama University, Juntendo University, KKR Takamatsu Hospital, Kyoto University, Nara Medical University, Hirosaki University, Public Central Hospital of Matto Ishikawa, Mimihara General Hospital, Takeda General Hospital, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. the patients with and less tha PSA 20ng/mL 2. the patients who are suspected as having prostate cancer 3. the patients who agreed with the informaed consent of the present study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of the significant cancer in the patients and biopsy cores of systematic and target biopsies | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactSunao Shoji
Tokai University School of Medicine Department of Urology
Outcome results
None listed