UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036940 |
|---|---|
| Receipt number | R000041559 |
| Scientific Title | prostate biopsy based on transrectal ultrasound and MRI fusion imaging |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2023/06/06 09:25:27 |
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Basic information
Public title
Examination about the usefulness in cancer localization diagnosis of prostate biopsy using BioJet system phase 4 study
Acronym
Biojet prostate biopsy
Scientific Title
prostate biopsy based on transrectal ultrasound and MRI fusion imaging
Scientific Title:Acronym
MRI-US fusion prostate biopsy
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether prostate biopsy performed using the BioJet system can improve diagnostic rates and accurate prostate cancer localization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a) Biopsy positive rate
b) Comparison of prostate biopsy 3D records and specimens in patients undergoing radical prostatectomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Prostate biopsy with BioJet
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
Target patients who meet all the following criteria
1) Patients with serum PSA level between 4.0 ng / ml and 20 ng / ml
2) PIRADS score 3 or more on MRI before biopsy
3) Patients 20 years of age or older at the time of consent acquisition
4) Patients who obtained written consent by the patient's own free will after sufficient understanding after participating in this study
Key exclusion criteria
I. A patient who is judged not to contribute to a patient's life prognosis by a definite diagnosis of prostate cancer
II. Patients suspected of developing prostate cancer with serum PSA> 20 ng / ml
III. Patients suspected of having advanced prostate cancer by rectal examination
IV. Patients suspected of having advanced prostate cancer by MRI
V. Patients who can not have prostate biopsy due to blood coagulation abnormality
VI. Patients who can not be under spinal anesthesia, sacral anesthesia or general anesthesia because they have allergies to anesthetic agents
VII. Other patients who were judged inappropriate by the doctor in charge of this study
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | ATSUSHI |
| Middle name | |
| Last name | TAKAMOATO |
Organization
Okayama University Hospital
Division name
Department of Urology
Zip code
7008558
Address
kita-ku, shikata-tyo, 2-5-1, okayama city, okayama
TEL
086-235-7287
p1v91oga@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Takamoto |
Organization
Okayama University Hospital
Division name
Department of Urology
Zip code
7008558
Address
kita-ku, shikata-tyo, 2-5-1, okayama city, okayama
TEL
0862357287
Homepage URL
p1v91oga@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Okayama University Hospital
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
kita-ku, shikata-tyo, 2-5-1
Tel
0862357287
p1v91oga@okayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041559
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| Registered date | File name |
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