UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004146 |
|---|---|
| Receipt number | R000004974 |
| Scientific Title | The clinical effect of Silodosin for lower urinary tract symptoms after permanent prostate brachytherapy |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2016/09/13 20:25:50 |
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Basic information
Public title
The clinical effect of Silodosin for lower urinary tract symptoms after permanent prostate brachytherapy
Acronym
The effect of Silodosin for LUTS after permanent prostate brachytherapy
Scientific Title
The clinical effect of Silodosin for lower urinary tract symptoms after permanent prostate brachytherapy
Scientific Title:Acronym
The effect of Silodosin for LUTS after permanent prostate brachytherapy
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of silodosin for LUTS after prostate brachytherapy by comparing outcomes assessed by IPSS, QOL, OABSS, IIEF-5 scores. Patients are randomized into two group according to dosage of silodosin (4mg / day vs 8mg / day).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
IPSS score, QOL score, OABSS score, IIEF-5 score, SF-8 score, EPIC score, Uroflowmetry Qmax
Key secondary outcomes
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Silodocin 8mg/day
Interventions/Control_2
Silodocin 4mg/day
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
Pathologically proven prostate cancer.
Patient who underwent prostate brachytherapy or prostate brachyterapy in combination with external beam radiation therapy.
Written informed consent can be obtained.
Key exclusion criteria
Patient with allergy against Silodocin.
Patient with neurogenic bladder, bladder neck constructure, urethral stenosis, vesical stone, or large bladder diverticulum.
Patient with active urinary tract infection.
Patient with severe renal dysfunction.
Patient with severe liver disease.
Patient who is considered to be inapropriate for this study by physisian.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Urology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6155
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu Muramaki |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Urology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6155
Homepage URL
muramaki@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Organization
Division
Category of Funding 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
神戸大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 02 | Day |
Last modified on
| 2016 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004974
