UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030652 |
|---|---|
| Receipt number | R000034995 |
| Scientific Title | Clinical study on oncological outocomes of enzalutamide in patients with castration-resistant prostate cancer:multi-institutional, retrospective observational study |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2019/01/01 09:15:43 |
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Basic information
Public title
Clinical study on oncological outocomes of enzalutamide in patients with castration-resistant prostate cancer:multi-institutional, retrospective observational study
Acronym
Clinical study of enzalutmide on castration-resistant prostate cancer
Scientific Title
Clinical study on oncological outocomes of enzalutamide in patients with castration-resistant prostate cancer:multi-institutional, retrospective observational study
Scientific Title:Acronym
Clinical study of enzalutmide on castration-resistant prostate cancer
Region
| Japan |
Condition
Condition
castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the prognostic factors of enzalutamide on castration-resistant prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
factors to predict the prognosis (overall survival)
Key secondary outcomes
PSA response rate
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
1) castration resistant prostate cancer treated with enzalumide
2) metastatic case
Key exclusion criteria
1) previous abiraterone treatment
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Suzuki |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8315
kazu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Suzuki |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8315
Homepage URL
kazu@gunma-u.ac.jp
Sponsor or person
Institute
Department of Urology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 01 | Month | 01 | 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
Total 241 CRPC patients were enrolled. Median PSA progression free survival was 7 months, and median overall survival was 31.3 months. Multivariate analysis showed that base line PSA levels, time to CRPC, history of chemotherapy, hemoglobin level and PSA reduction rate of 50% at 4 weeks after initiation of enzalutamide treatment were significant prognostic facotrs. In pre-docetaxel state, PSA reduction rates of 75% was a significant prognostic factor. In acquired resistant state, short PSA doubling time was a significant prognostic factor.
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
The present study showed significant prognostic factors to predict effetiveness of enzalutamide treatment for CRPC.
Management information
Registered date
| 2017 | Year | 12 | Month | 31 | Day |
Last modified on
| 2019 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034995
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
