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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000252
Receipt No. R000000318
Scientific Title Outcome study of hormonal therapy for prostate cancer in Japan
Date of disclosure of the study information 2005/09/29
Last modified on 2011/06/04

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Basic information
Public title Outcome study of hormonal therapy for prostate cancer in Japan
Acronym Outcome study of hormonal therapy for prostate cancer in Japan
Scientific Title Outcome study of hormonal therapy for prostate cancer in Japan
Scientific Title:Acronym Outcome study of hormonal therapy for prostate cancer in Japan
Region
Japan

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

Objectives
Narrative objectives1 Efficacy of hormonal therapy for all stage of prostate cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Failure free survival
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 Patients who were newly stated hormone therapy on prostate cancer after January 2001 to December 2003
Key exclusion criteria None
Target sample size 24000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiyuki Usami MD, Hideyuki Akaza MD
Organization Osaka Medical center for cancer and cardiovascular disease,
University of Tsukuba
Division name Department of Urology
Zip code
Address Osaka, Tsukuba
TEL 029-853-3223
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Akaza MD
Organization University of Tsukuba
Division name Department of Urology
Zip code
Address
TEL
Homepage URL http://www.j-cap.net/
Email

Sponsor
Institute J-CaP study group
Institute
Department

Funding Source
Organization The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization Non profit foundation
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
2005 Year 09 Month 29 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 No longer recruiting
Date of protocol fixation
2001 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2001 Year 08 Month 01 Day
Last follow-up date
2006 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participating investigator reports failure and survival status every 3 months.

Management information
Registered date
2005 Year 09 Month 29 Day
Last modified on
2011 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000318

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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