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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019493
Receipt No. R000022542
Scientific Title The impact of serum testosterone level as prognosis factor for CRPC with enzalutamide or Abraterone
Date of disclosure of the study information 2015/10/26
Last modified on 2015/10/27

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Basic information
Public title The impact of serum testosterone level as prognosis factor for CRPC with enzalutamide or Abraterone
Acronym PC-TES
Scientific Title The impact of serum testosterone level as prognosis factor for CRPC with enzalutamide or Abraterone
Scientific Title:Acronym PC-TES
Region
Japan

Condition
Condition Castration resistant prostate cancer :CRPC
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impact of serum testosterone level as prognosis factor of progression free survival for CRPC with enzalutamide or Abraterone

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression 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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male
Key inclusion criteria The candidate for administration with enzalutamide or Abraterone in CRPC

Key exclusion criteria without informed consent to entry in this study
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nirihito Soga
Organization Aichi cancer center hospital
Division name Urology
Zip code
Address Knokodenn1-1, Chikusa-ku, Nagoya
TEL 052-762-6111
Email n-soga@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nirihito Soga
Organization Aichi cancer center hospital
Division name Urology
Zip code
Address Knokodenn1-1, Chikusa-ku, Nagoya
TEL 052-762-6111
Homepage URL
Email n-soga@aichi-cc.jp

Sponsor
Institute Aichi cancer center hospital
Institute
Department

Funding Source
Organization Foundation of aichi cancer research
Organization
Division
Category of Funding Organization Local Government
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 10 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially 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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design : Cohort study
Material and recruitment : Between October 26th 2015 and December 31th 2017, the all cases who are accordance with selection criteria, visit our hospital, will entry in this study
Evaluation factors : serum testosterone level, prostate specific antigen, CT, bone scintigraphy

Management information
Registered date
2015 Year 10 Month 26 Day
Last modified on
2015 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022542

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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