UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017527 |
|---|---|
| Receipt number | 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 17:53:00 |
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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
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
nozomis@mbj.nifty.com
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020307
