UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029670 |
|---|---|
| Receipt number | R000033905 |
| Scientific Title | The evaluation of BjoJet system for accurate prostate biopsy for the patients with suspicious prostate cancer |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2020/04/27 07:46:47 |
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Basic information
Public title
The evaluation of BjoJet system for accurate prostate biopsy for the patients with suspicious prostate cancer
Acronym
The evaluation of BjoJet system for accurate prostate biopsy
Scientific Title
The evaluation of BjoJet system for accurate prostate biopsy for the patients with suspicious prostate cancer
Scientific Title:Acronym
The evaluation of BjoJet system for accurate prostate biopsy
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of BioJet system for accurate prostate cancer diagnosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a) Positive biopsy rate
b) Comparison with 3D biopsy information and cancer localization derived from radical prostatectomy specimens
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 by Biojet system
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1)2.5 ng/ml=< serum PSA= <50ng/ml
2) Suspicious of prostate cancer with digital rectal examination (DRE)
3) Suspicious of prostate cancer with MRI
Key exclusion criteria
1) Prostate cancer with non-clinical significant disease
2) PSA =>50ng/ml
3) Suspicious of advanced prostate cancer by DRE
4) Suspicious of advanced prostate cancer by MRI
5) Patients who are not candidate for prostate biopsy due to abnormalities in coagulation
6) Patients who are not candidate for prostate biopsy due to allergy to anesthesia
7) Patients who are not appripriate for entry to the trial decided by physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ogawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
6068507
Address
54 Kawaharacho Shogoin Sakyoku Kyoto
TEL
075-751-3337
ogawao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shusuke |
| Middle name | |
| Last name | Akamatsu |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
6068507
Address
54 Kawaharacho Shogoin Sakyoku Kyoto
TEL
075-751-3337
Homepage URL
takahi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine and Kyot University Hospital Ethics Committe
Address
Konoe Yoshida Sakyoku Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2018 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 23 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033905
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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