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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029102
Receipt No. R000033249
Scientific Title Prostate biopsy with fusion imaging of magnetic resonance imaging and transrectal ultrasound
Date of disclosure of the study information 2017/09/12
Last modified on 2018/03/15

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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 Urology
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficiency of transperineal targeted biopsy with real-time fusion image (BioJet system) of multiparametric-MRI (mpMRI) and transrectal ultrasound (TRUS) image for the diagnosis of significant prostate cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate the number of adverse events, hematuria, prostatitis and cancer detection rate of transperineal targeted prostate biopsy with BioJet system compared to systematic biopsy.
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 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
・Localized prostate cancer was suspected
・Significant cancer was suspected by MRI
・To obtain 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 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhito Miyazawa
Organization Kanazawa Medical University
Division name Department of Urology
Zip code
Address 1-1, Daigaku, Uchinada, Kahoku, Ishikawa, 920-0293, Japan
TEL 076-286-2211
Email miyazawa@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ippei Chikazawa
Organization Kanazawa Medical University
Division name Department of Urology
Zip code
Address 1-1, Daigaku, Uchinada, Kahoku, Ishikawa, 920-0293, Japan
TEL 076-286-2211
Homepage URL
Email i-chika@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Kanazawa Medical University
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 12 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
2017 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
2018 Year 03 Month 13 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 12 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033249

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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