UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical effect of Silodosin for lower urinary tract symptoms after permanent prostate brachytherapy
Title of the study (Brief title)	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	Masato Fujisawa
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6155
Email

Public contact
Name of contact person	Mototsugu Muramaki
Organization	Kobe University Graduate School of Medicine
Division name	Division of Urology
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6155
Homepage URL
Email	muramaki@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2010 Year 09 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004974