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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023240
Receipt No. R000026780
Scientific Title Real time MRI-TRUS fusion image-guided transperineal target biopsy for the detection of the significant prostate cancer with BioJet system
Date of disclosure of the study information 2016/07/20
Last modified on 2017/07/21

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Basic information
Public title Real time MRI-TRUS fusion image-guided transperineal target biopsy for the detection of the significant prostate cancer with BioJet system
Acronym MRI-TRUS fusion image-guided biopsy for detection of the significant prostate cancer with BioJet system
Scientific Title Real time MRI-TRUS fusion image-guided transperineal target biopsy for the detection of the significant prostate cancer with BioJet system
Scientific Title:Acronym MRI-TRUS fusion image-guided biopsy for detection of the significant prostate cancer with BioJet system
Region
Japan

Condition
Condition Prostate cacer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To report clinical results of manually controlled targeted biopsy with real-time multiparametric magnetic resonance image (mpMRI)-transrectal ultrasound (TRUS) fusion images for the diagnosis of prostate cancer using the BioJet system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Target biopsies for each cancer-suspicious lesion and 12 systematic biopsies would be performed using the BioJet system. Pathological findings of targeted and systematic biopsies were analyzed.
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
Device,equipment
Interventions/Control_1 Target biopsies for each cancer-suspicious lesion and 12 systematic biopsies would be performed using the BioJet system. Pathological findings of targeted and systematic biopsies were analyzed.
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 1. The patients with PSA level greater than 4.0 ng/ml and less than 20 ng/ml were performed mpMRI prospectively.
2. Consecutive patients with suspected prostate cancer from multiparametric MRI were recruited prospectively.
Key exclusion criteria The patients with PSA level greater than 20ng/ml.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sunao Shoji
Organization Tokai Univeristy Hachioji Hospital
Division name Department of Urology
Zip code
Address 1838 Ishikawa-machi, Hachioji, Tokyo, Japan, 192-0032
TEL 042-639-1111
Email sunashoj@mail.goo.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sunao Shoji
Organization Tokai Univeristy Hachioji Hospital
Division name Department of Urology
Zip code
Address 1838 Ishikawa-machi, Hachioji, Tokyo, Japan, 192-0032
TEL 042-639-1111
Homepage URL
Email sunashoj@mail.goo.ne.jp

Sponsor
Institute Department of Urology, Tokai University Hachioji Hospital
Institute
Department

Funding Source
Organization Tokai Universty School of Medicine
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
Address
Tel
Email

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 東海大学医学部付属八王子病院

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2013 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 24 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
2016 Year 07 Month 20 Day
Last modified on
2017 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026780

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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