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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019277
Receipt No. 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

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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
Email 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
Email nterada@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021645

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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