UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005786 |
|---|---|
| Receipt number | R000006846 |
| Scientific Title | The effect of alpha1-AR antagonists for lower urinary tract symptoms in patients undergoing prostate 125I brachytherapy for prostate carcinoma |
| Date of disclosure of the study information | 2011/06/16 |
| Last modified on | 2014/01/20 09:35:51 |
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Basic information
Public title
The effect of alpha1-AR antagonists for lower urinary tract symptoms in patients undergoing prostate 125I brachytherapy for prostate carcinoma
Acronym
Efficacy of alpha1-AR antagonists in patients undergoing brachytherapy
Scientific Title
The effect of alpha1-AR antagonists for lower urinary tract symptoms in patients undergoing prostate 125I brachytherapy for prostate carcinoma
Scientific Title:Acronym
Efficacy of alpha1-AR antagonists in patients undergoing brachytherapy
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effectiveness of silodosin at reducing urinary symptoms in patients undergoing PI to treat prostate carcinoma. Patients were randomly assigned to either a silodosin (8 mg silodosin daily) group or a control group. Objective changes in urination status in terms of bladder function and prostatic obstruction were assessed using a pressure flow study, subjective symptoms and quality of life were assessed using the International Prostate Symptom Score (I-PSS), over active bladder symptom score (OABSS)and erectile function was assessed using the International Index of Erectile Function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
IPSS total score
Key secondary outcomes
Pressure flow study, I-PSS storage subscores, I-PSS voiding subscores ,QOL, OABSS, IIEF5, Uroflowmetry, PVR
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
8 mg silodosin daily
Interventions/Control_2
control group
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
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu UEMURA |
Organization
Kinki University Faculty of Medicine
Division name
Department of Urology
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobutaka SHIMIZU |
Organization
Kinki University Faculty of Medicine
Division name
Department of Urology
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama Osaka 589-8511, JAPAN
TEL
072-366-0221
Homepage URL
shimizun@med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kinki University Faculty 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
近畿大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s00345-014-1239-z
Number of participants that the trial has enrolled
Results
AUA-2011 Abstract No.2161
EAU-2012 Abstract No.732
World J Urol. 2014 Jan 17
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
| 2008 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 16 | Day |
Last modified on
| 2014 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006846
