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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005786
Receipt No. 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

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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
Email

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
Email shimizun@med.kindai.ac.jp

Sponsor
Institute Kinki University Faculty of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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