UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019493 |
|---|---|
| Receipt number | 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 15:00:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
n-soga@aichi-cc.jp
Sponsor or person
Institute
Aichi cancer center hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022542
