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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035120
Receipt No. R000040030
Official scientific title of the study Observational study for clinical outcome and quality of life in patients after each treatment for prostate cancer.
Date of disclosure of the study information 2018/12/06
Last modified on 2018/12/03

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Basic information
Official scientific title of the study Observational study for clinical outcome and quality of life in patients after each treatment for prostate cancer.
Title of the study (Brief title) Clinical outcome and QOL in patients after treatment for prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 Clinical outcome and QOL after each treatment for prostate cancer
Basic objectives2 Others
Basic objectives -Others Comparison of clinical outcomes and change of QOL among treatments.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biochemical failure
Cancer specific survival
Overall survival
Key secondary outcomes chronological change of QOL after each treatment

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Diagnosed as prostate cancer by pathological findings
Stage A,B,C and D
more than 20 years old
patients treated for prostate cancer
Key exclusion criteria patients who cannot answer the questionnaires
patients without informed consent
Target sample size 1250

Research contact person
Name of lead principal investigator Yasushi Nakai
Organization Nara Medical University
Division name Department of Urology
Address Kashihara
TEL 0744-22-3051
Email nakaiyasusiuro@live.jp

Public contact
Name of contact person Yasushi Nakai
Organization Nara Medical University
Division name Department of Urology
Address Kashihara
TEL 0744-22-3051
Homepage URL
Email nakaiyasusiuro@live.jp

Sponsor
Institute Nara Medical University
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)

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
2018 Year 12 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 06 Day
Anticipated trial start date
2018 Year 12 Month 06 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 QOL and clinical outcome

Management information
Registered date
2018 Year 12 Month 03 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040030

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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