UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029223 |
|---|---|
| Receipt number | R000033403 |
| Scientific Title | Optimization of prostate needle biopsy for focal targeted therapy in prostate cancer |
| Date of disclosure of the study information | 2017/09/23 |
| Last modified on | 2017/09/21 00:42:42 |
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Basic information
Public title
Optimization of prostate needle biopsy for focal targeted therapy in prostate cancer
Acronym
Optimization of prostate needle biopsy for focal targeted therapy in prostate cancer
Scientific Title
Optimization of prostate needle biopsy for focal targeted therapy in prostate cancer
Scientific Title:Acronym
Optimization of prostate needle biopsy for focal targeted therapy in prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop optimized methods to detect significant prostate cancer by image-guided needle biopsy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficiency of detecting prostate cancer with gleason score 7 or higher from targeted regions
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
| Maneuver |
Interventions/Control_1
Targeted 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Male patients suspicious of cancer who have targeted region with PI-RADS score 3 or more by MRI
Key exclusion criteria
Patients with a contraindication for the administration of gadolinium contrast media.
Patients determined to be ineligible to principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Ukimura |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Urology
Zip code
Address
465 Kajii-cho Kamigyo-ku Kyoto 602-8566 Japan
TEL
075-251-5595
ukimura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takumi Shiraishi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Urology
Zip code
Address
465 Kajii-cho Kamigyo-ku Kyoto 602-8566 Japan
TEL
075-251-5595
Homepage URL
takumi14@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto Min-iren Chuo Hospital
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
京都府立医科大学付属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | 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 | 09 | Month | 21 | Day |
Last modified on
| 2017 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033403
