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

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 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


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

Value
https://center6.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