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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017527
Receipt No. R000020307
Scientific Title Longitudinal comparison of quality of life after real-time tumor-tracking intensity-modulated radiation therapy and radical prostatectomy inpatients with localized prostate cancer
Date of disclosure of the study information 2015/05/12
Last modified on 2015/05/12

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Basic information
Public title Longitudinal comparison of quality of life after real-time tumor-tracking intensity-modulated radiation therapy and radical prostatectomy inpatients with localized prostate cancer
Acronym Longitudinal comparison of quality of life after real-time tumor-tracking intensity-modulated radiation therapy and radical prostatectomy inpatients with localized prostate cancer
Scientific Title Longitudinal comparison of quality of life after real-time tumor-tracking intensity-modulated radiation therapy and radical prostatectomy inpatients with localized prostate cancer
Scientific Title:Acronym Longitudinal comparison of quality of life after real-time tumor-tracking intensity-modulated radiation therapy and radical prostatectomy inpatients with localized prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To compare the global Hr-QOL, PC disease-specific QOL, and emotional health in patients with localized PC who underwent
RT-IMRT or RP in our hospital.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Health-related QOL(Global-, Disease-specific-, Psycological-)
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Non-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
Other
Interventions/Control_1 IMRT
Interventions/Control_2 Radical prostatectomy
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 1.Pathological findings(prostate cancer) by prostate biopsy
2.No metastases bonescintigraphy and CT
3.Not previously received endocrine therapy
4.Patients completed the questionnaires of health-related QOL
Key exclusion criteria Patients who are judged as an nappropriate patient by cheif investigator
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuo Shinohara
Organization Hokkaido University Graduate school of medicine
Division name Department of Renal and Genitourinary surgery
Zip code
Address North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5966
Email nozomis@mbj.nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuo Shinohara
Organization Hokkaido University Graduate School of Medicine
Division name Department of Renal and Genitourinary surgery
Zip code
Address North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5966
Homepage URL
Email nozomis@mbj.nifty.com

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization none
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
2015 Year 05 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information r

Management information
Registered date
2015 Year 05 Month 12 Day
Last modified on
2015 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020307

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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