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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025095
Receipt No. R000028856
Official scientific title of the study Evaluation of intravesical urine volume and prostate position in radiotherapy of prostate cancer
Date of disclosure of the study information 2016/11/30
Last modified on 2016/11/30

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Basic information
Official scientific title of the study Evaluation of intravesical urine volume and prostate position in radiotherapy of prostate cancer
Title of the study (Brief title) 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
Name of lead principal investigator Hiroki Shirato
Organization Hokkaido university graduate school of medicine
Division name Department of Radiation medicine
Address Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo, Hokkaido
TEL 011-706-5977
Email shirato@med.hokudai.ac.jp

Public contact
Name of contact person Kentaro Nishioka
Organization Hokkaido university graduate school of medicine
Division name Department of Radiation oncology
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)

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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 09 Month 21 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2016 Year 11 Month 30 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 Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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