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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034165
Receipt No. R000038948
Scientific Title Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Date of disclosure of the study information 2018/09/17
Last modified on 2019/03/16

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Basic information
Public title Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Acronym Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Scientific Title Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Scientific Title:Acronym Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
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 MRI/US fusion targeted biopsy using the 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 Cancer detection rate, target biopsies for each cancer-suspicious lesion would be performed using the BioJet system.
Key secondary outcomes Evaluation of safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria ・Serum PSA level: 4.0-20.0ng/ml
・Significant cancer was suspected by MRI
・To obtain informed consent
Key exclusion criteria ・Anal stenosis
・Diabetes
・Infection nest in perineum site
・Clear hypoechoic area was detected by US on cancer suspecting region
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shin
Middle name
Last name Egawa
Organization Jikei University School of Medicine
Division name Department of Urology
Zip code 1058461
Address 3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
TEL 03-3433-1111
Email s-egpro@jikei.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Sasaki
Organization Jikei University School of Medicine
Division name Department of Urology
Zip code 1058461
Address 3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, JAPAN
TEL 03-3433-1111
Homepage URL
Email hs06@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Jikei University IRB
Address 3-25-8, Nishishinbashi, Minato-ku, Tokyo
Tel 03-3433-1111
Email rinri@jikei.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 09 Month 17 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 05 Month 16 Day
Date of IRB
2017 Year 05 Month 16 Day
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 15 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038948

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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