UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025911 |
|---|---|
| Receipt number | 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 20:08:51 |
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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
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
yhakozaki11012@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Police Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029792
