UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015331 |
|---|---|
| Receipt number | R000017826 |
| Scientific Title | A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer |
| Date of disclosure of the study information | 2014/10/02 |
| Last modified on | 2020/10/07 21:34:05 |
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Basic information
Public title
A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Acronym
A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Scientific Title
A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Scientific Title:Acronym
A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Region
| Japan |
Condition
Condition
suspected prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the safety and efficacy of three-dimensional prostate biopsy method
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cancer detection rate
rate of occurrence of a complication
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
| Maneuver |
Interventions/Control_1
three-dimensional prostate 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
1.patients with susupected prostate cancer who had previously experience of prostate biopsies
2.patients who satisfied all of criteria as follows
a)patients suspected prostate cancer at apex or ventral portion by MRI
b)patients who have prostate volume more than 30ml
c)patients who have prostate volume less than 30ml and have middle lobe enlargement
Key exclusion criteria
1.patients who cannot undergo lumbar spinal anesthesia
2.patients who decide not to join this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeo Kosaka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
takemduro@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Kobayashi |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
shadow87jp@yahoo.co.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
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
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
| 2014 | Year | 10 | Month | 02 | 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 | 10 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017826
