UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dutasteride for relieving benign prostatic obstruction
Title of the study (Brief title)	AVO PFS Study
Region	Japan

Condition
Condition	Benign Prostatic Hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of dutasteride for relieving benign prostatic obstruction (BPO) by pressure flow study (PFS)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from baseline in PFS parameter
Key secondary outcomes	IPSS OABSS Urinary flow Post voided residual volume Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dutasteride 0.5mg/day for 24 months
Interventions/Control_2
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Subjects who meet all the following criteria will be enrolled. 1 Age >= 50 yrs 2 IPSS >= 8 3 IPSS QOL >= 3 4 Prostate volume >= 25mL measured by abdominal ultarsonograpy 5 Qmax < 15mL/sec
Key exclusion criteria	Subjects who apply to any of the following criteria will not be enrolled. 1 Use of any alpha-blocker within 4 weeks 2 Previous use of 5ARIs or antiandrogens 3 History of prostate cancer 4 History of acute urinary retention (AUR) within 3 months 5 Previous prostatic surgery
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshihisa Matsukawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Urology
Address	65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan
TEL	+81-52-744-2985
Email

Public contact
Name of contact person	Yoshihisa Matsukawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Urology
Address	65 Tsuruma-Cho, Showa-Ku, Nagoya, 466-8550, Japan
TEL	+81-52-744-2985
Homepage URL
Email	yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Urology, Nagoya University School of Medicine
Institute
Department

Funding Source
Organization	GlaxoSmithKline
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 23 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date	2012 Year 12 Month 01 Day
Date of closure to data entry	2013 Year 01 Month 01 Day
Date trial data considered complete	2013 Year 01 Month 01 Day
Date analysis concluded	2014 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Dutasteride was effective for relieving LUTS by improving storage and voiding function as well as subjective symptoms in patients with BPH.
Other related information

Management information
Registered date	2010 Year 10 Month 26 Day
Last modified on	2017 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005331