UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of intravesical urine volume and prostate position in radiotherapy of prostate cancer
Acronym	Evaluation of urine volume and prostate position
Scientific Title	Evaluation of intravesical urine volume and prostate position in radiotherapy of prostate cancer
Scientific Title:Acronym	Evaluation of urine volume and prostate position
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the influence of intravesical urine volume on prostate position during radiotherapy for prostate cancer.
Basic objectives2	Others
Basic objectives -Others	Internal organ motion
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between urine volume and positional changes of prostate during radiotherapy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patient with prostate cancer who was received proton beam therapy at Hokkaido University Hospital from 1 April 2016 until 31 August 2016. Those who refuse to participate in this research.
Key exclusion criteria	1. Patients who refused urine volume measurement by ultrasonic diagnostic equipment. 2. Patients who could not be performed prostate location verification using real-time tumor tracking system. 3. Other patients whose research managers judged inappropriate as research subjects.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiroki Shirato
Organization	Hokkaido university graduate school of medicine
Division name	Department of Radiation medicine
Zip code
Address	Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5977
Email	shirato@med.hokudai.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Kentaro Nishioka
Organization	Hokkaido university graduate school of medicine
Division name	Department of Radiation oncology
Zip code
Address	Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5977
Homepage URL
Email	k.nishioka@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido university
Institute
Department

Funding Source
Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 30 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
Results
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	2016 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date	2016 Year 09 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a retrospective observation study using existing clinical information acquired from April 1st to August 31st 2016, and the results are currently being analyzed.

Management information
Registered date	2016 Year 11 Month 30 Day
Last modified on	2017 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028856

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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