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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040802
Receipt No. R000046562
Scientific Title The effect of treatment modality on health-related quality of life in elderly patients with prostate cancer: A prospective observational study
Date of disclosure of the study information 2020/07/01
Last modified on 2020/07/02

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Basic information
Public title The effect of treatment modality on health-related quality of life in elderly patients with prostate cancer: A prospective observational study
Acronym The effect of treatment modality on health-related quality of life in elderly patients with prostate cancer: A prospective observational study
Scientific Title The effect of treatment modality on health-related quality of life in elderly patients with prostate cancer: A prospective observational study
Scientific Title:Acronym The effect of treatment modality on health-related quality of life in elderly patients with prostate cancer: A prospective observational study
Region
Japan

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

Objectives
Narrative objectives1 To assess the effect of treatment modality on health-related quality of life in elderly patients with prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HRQOL comparison: radical prostatectomy vs. radiation therapy in elderly patients (>=75 yrs)
Key secondary outcomes HRQOL comparison: radical prostatectomy vs. radiation therapy in elderly patients (<75 yrs)
Frailty comparison:radical prostatectomy vs. radiation therapy in elderly patients (>=75 yrs)

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
100 years-old >
Gender Male
Key inclusion criteria 1) Patients with localized prostate cancer treated with radical prostatectomy or radiation therapy, 2)HRQOL evaluation (EPIC and SF-8) at baseline, 3, 6, 9, and 12 months after treatment,
Key exclusion criteria 1) Patients with locally advanced (T4 or N+) or metastatic prostate cancer treated with radical prostatectomy or radiation therapy, 2) not treated with radical prostatectomy or radiation therapy,and 3)without HRQOL evaluation (EPIC and SF-8) at baseline, 3 and 12 months after treatment.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Hatakeyama
Organization Hirosaki Univ
Division name Urology
Zip code 036-8562
Address Hirosaki
TEL 0172395091
Email shingorilla2@gmail.com

Public contact
Name of contact person
1st name Shingo
Middle name Hatakeyama
Last name Hatakeyama
Organization Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name Urology
Zip code 036-8562
Address Hirosaki
TEL 0172395091
Homepage URL
Email shingorilla2@gmail.com

Sponsor
Institute Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Dept. of Urology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dept. of Urology, Hirosaki University Graduate School of Medicine
Address Hirosaki
Tel +81172395091
Email rinri@hirosaki-u.ac.jp

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
2020 Year 07 Month 01 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
2015 Year 02 Month 01 Day
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
2035 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The primary outcome is to compare HRQOL between surgery and radiotherapy. Secondary and exploratory outcomes are to compare frailty and oncological outcomes between the groups, respectively.

Management information
Registered date
2020 Year 06 Month 17 Day
Last modified on
2020 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046562

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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