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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025911
Receipt No. R000029792
Scientific Title A prospective study of magnetic resonance imaging and ultrasonography (MRI/US)-fusion targeted biopsy and concurrent systematic biopsy with the average of 18-cores to detect clinically significant prostate cancer
Date of disclosure of the study information 2017/01/30
Last modified on 2017/01/30

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Basic information
Public title A prospective study of magnetic resonance imaging and ultrasonography (MRI/US)-fusion targeted biopsy and concurrent systematic biopsy with the average of 18-cores to detect clinically significant prostate cancer
Acronym A prospective study of magnetic resonance imaging and ultrasonography (MRI/US)-fusion targeted biopsy and concurrent systematic biopsy with the average of 18-cores to detect clinically significant prostate cancer
Scientific Title A prospective study of magnetic resonance imaging and ultrasonography (MRI/US)-fusion targeted biopsy and concurrent systematic biopsy with the average of 18-cores to detect clinically significant prostate cancer
Scientific Title:Acronym A prospective study of magnetic resonance imaging and ultrasonography (MRI/US)-fusion targeted biopsy and concurrent systematic biopsy with the average of 18-cores to detect clinically significant prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To compare the detection rate of clinically significant prostate cancer (CSPC) between magnetic resonance imaging and ultrasonography (MRI/US)-fusion-targeted biopsy (TB), systematic biopsy (SB) and combination of TB and SB.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes detection rates of clinically significant prostate cancer
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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 We add MRI/US fusion targeted biopsy with concurrent systematic biopsy
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 Patients having cancer suspicious lesions on MRI were recruited in this study
Key exclusion criteria Patients who MRI/US fusion-targeted and concurrent systematic biopsies were not performed
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Matsushima
Organization Tokyo Metropolitan Police Hospital
Division name Department of Urology
Zip code
Address 4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan
TEL +81-03-5343-5611
Email hmatsu53@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Hakozaki
Organization Tokyo Metropolitan Police Hospital
Division name Department of Urology
Zip code
Address 4-22-1 Nakano, Nakano-ku, Tokyo, 164-0001, Japan
TEL +81-03-5343-5611
Homepage URL
Email yhakozaki11012@gmail.com

Sponsor
Institute Tokyo Metropolitan Police Hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan Police Hospital
Organization
Division
Category of Funding Organization Profit organization
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 01 Month 30 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
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 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 01 Month 30 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029792

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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