UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019277 |
|---|---|
| Receipt number | R000021645 |
| Scientific Title | Evaluation of the mechanisms for castration-resistance using CRPC tissues to predict the efficacy of Enzalutamide |
| Date of disclosure of the study information | 2015/10/08 |
| Last modified on | 2015/10/08 15:23:12 |
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Basic information
Public title
Evaluation of the mechanisms for castration-resistance using CRPC tissues to predict the efficacy of Enzalutamide
Acronym
Evaluation of the mechanisms for castration-resistance using CRPC tissues to predict the efficacy of Enzalutamide
Scientific Title
Evaluation of the mechanisms for castration-resistance using CRPC tissues to predict the efficacy of Enzalutamide
Scientific Title:Acronym
Evaluation of the mechanisms for castration-resistance using CRPC tissues to predict the efficacy of Enzalutamide
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To find novel biomarkers for predicting the efficacy of Enzalutamide usung biopsy specimens of castration resistant prostate cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze gene mutation or expression profiles in the local or metastatic biopsy specimens of castration resistant prostate cancer patients.
To find novel biomarkers to ecaluate the gene mutation or expression in blood or urine sampls.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
Prostate biopsy before Enzalutamide treatement for CRPC
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
Castration resistant prostate cancer patients who are going to receive Enzalutamide treatment are included in this study.
Local recurrent cancer is detected by MRI.
Key exclusion criteria
Patients who are unable to receive prostate biopsy safely.
Pathents with severe side effect by previous prostate biopsy.
Allergy to Enzalutamide.
Refuse the study.
Age is younger than 20 years old.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Ogawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3325
ogawao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Terada |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3337
Homepage URL
nterada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 08 | Day |
Last modified on
| 2015 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021645
