UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical effect of Cyclooxygenase (COX)-2 selective inhibitors on pollakisuria and lumbar- abdominal pain in patients with prostate cancer who undergo interstitial seed implantation - Randomized control trial-
Title of the study (Brief title)	The clinical effect of Cox-2 inhibitor on symptoms in patients who undergo 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 assess the clinical effect of COX-2 inhibitor on pallakisuria and lumbar-abdominal pain in patients who undergo prostate brachytherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of rate in IPSS, QOL-index, OABSS and QOL questionnaire (SF8 and EPIC) during 3 months after seed implantation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	alpha-1 blocker
Interventions/Control_2	alpha-1 blocker + COX-2 inhibitor
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	newly diagnosed localized prostate cancer patients
Key exclusion criteria	Patients with severe cardiac disease, severe liver dysfunction and severe renal dysfunction
Target sample size	150

Research contact person
Name of lead principal investigator	Nobumichi Tanaka
Organization	Nara Medical University
Division name	Department of Urology
Address	Shijyocho840, Kashihara, Japan
TEL	0744-22-3051
Email	sendo@naramed-u.ac.jp

Public contact
Name of contact person	Nobumichi Tanaka
Organization	Nara Medical University
Division name	Department of Urology
Address	Shijyocho840, Kashihara, Japan
TEL	0744-22-3051
Homepage URL
Email	sendo@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 21 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 03 Month 23 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2014 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2014 Year 09 Month 30 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 05 Month 21 Day
Last modified on	2018 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004104