UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of mirabegron for voiding disorders in patient who underwent prostate low-dose-rate brachytherapy
Acronym	Efficacy of mirabegron in patient treathed with brachytherapy
Scientific Title	Efficacy of mirabegron for voiding disorders in patient who underwent prostate low-dose-rate brachytherapy
Scientific Title:Acronym	Efficacy of mirabegron in patient treathed with brachytherapy
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy for voiding disorder in patients who underwent low-dose-rate brachytherapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the change from baseline to three months later after brachytherapy in mean volume voided per micturition
Key secondary outcomes	the change from baseline to three months later after brachytherapy in IPSS,OABSS, and EPIC the change from baseline to three months later after brachytherapy in maximum urinary flow rate, residual urine volume, and mean number of micturitions per 24 hours.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatments were administered once daily (tamsrosin 0.2mg) during 12 months after low-dose-rate brachytherapy
Interventions/Control_2	Treatments were administered once daily (mirabegron 50mg) during 3 months after low-dose-rate brachytherapy
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	85 years-old >=
Gender	Male
Key inclusion criteria	patients who underwent low-dose-rate brachytherapy
Key exclusion criteria	considered unsuitable for the trial by doctors residual urine volume greater than 100 ml Qmax less than 5 ml per second contraindicated to medication with mirabegron history of urinary retention performance of clean intermittent catheterization
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Nakai
Organization	Nara Medical University
Division name	Department of Urology
Zip code	6348522
Address	840 Shijo-cho, Kashihara-shi, Nara, Japan
TEL	0744-22-3051
Email	nakaiyasushi@naramed-u.ac.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Nakai
Organization	Nara Medical University
Division name	Department of Urology
Zip code	6348522
Address	840 Shijo-cho, Kashihara-shi, Nara, Japan
TEL	0744-22-3051
Homepage URL
Email	nakaiyasushi@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University Department of Urology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara Medical University
Address	840 Shijyocho Kashihara Nara
Tel	0744-22-3051
Email	nakaiyasushi@naramed-u.ac.jp

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	2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	218
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The results will be reported at ASTRO in 25th-28th October.
Date of the first journal publication of results	2020 Year 10 Month 25 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD	None
IPD sharing Plan description	None

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 20 Day
Date of IRB	2016 Year 08 Month 17 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2018 Year 12 Month 03 Day
Date of closure to data entry	2018 Year 12 Month 26 Day
Date trial data considered complete	2018 Year 12 Month 26 Day
Date analysis concluded	2019 Year 07 Month 14 Day

Other
Other related information

Management information
Registered date	2016 Year 06 Month 05 Day
Last modified on	2020 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026051

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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