UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019325 |
|---|---|
| Receipt number | R000022345 |
| Scientific Title | Enzalutamide treatment sensitivity recovery effect of docetaxel treatment after relapse of enzalutamide treatment for castration-resistant prostate cancer patients |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2020/10/16 10:10:36 |
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Basic information
Public title
Enzalutamide treatment sensitivity recovery effect of docetaxel treatment after relapse of enzalutamide treatment for castration-resistant prostate cancer patients
Acronym
ESRED study
Scientific Title
Enzalutamide treatment sensitivity recovery effect of docetaxel treatment after relapse of enzalutamide treatment for castration-resistant prostate cancer patients
Scientific Title:Acronym
ESRED study
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploring enzalutamide treatment sensitivity recovery effect of docetaxel treatment after relapse of enzalutamide treatment for castration-resistant prostate cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Biochemical-free survival rate (Prostate specific antigen progression free survival rate (PSA-PFS)) after enzalutamide retreatment
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Enzaltamide 160mg per day by oral after docetaxel (at a dose of 70 mg/m2 every three or four weeks for six cycles)
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
1. 20 years old or more
2. Diagnosed as prostate cancer by histological examination
3. Testosterone < 50ng/dL
4. Progression on the image or PSA relapse
5. 2 months or more has passed from operation for metastasis or radiation therapy.
6. PS of ECOG; 0-2
7. Liver and renal function are adequate
8. Life expectancy is more than 6 months
Key exclusion criteria
1. Patients treated by chemotherapy
2. Patients judged to be inappropriate to perform this study by investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Nishiyama |
Organization
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Division name
Department of Urology
Zip code
Address
Urasa 4132, Minamiuonumashi, Niigata 949-7302, Japan
TEL
025-777-3200
nisiyama@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Nishiyama |
Organization
Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital
Division name
Department of Urology
Zip code
Address
Urasa 4132, Minamiuonumashi, Niigata 949-7302, Japan
TEL
025-777-3200
Homepage URL
nisiyama@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Urology
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization
Self funding
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 | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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 | 13 | Day |
Last modified on
| 2020 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022345
