UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015529 |
|---|---|
| Receipt number | R000018040 |
| Scientific Title | A multicenter randomized Phase III trial of enzalutamide versus abiraterone as a first-line endocrine therapy for castration-resistant prostate cancer |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2022/11/01 11:42:09 |
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Basic information
Public title
A multicenter randomized Phase III trial of enzalutamide versus abiraterone as a first-line endocrine therapy for castration-resistant prostate cancer
Acronym
EN-AB-LE Study for PCa
Scientific Title
A multicenter randomized Phase III trial of enzalutamide versus abiraterone as a first-line endocrine therapy for castration-resistant prostate cancer
Scientific Title:Acronym
EN-AB-LE Study for PCa
Region
| Japan |
Condition
Condition
castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of enzalutamide for castration-resistant prostate cancer with comparing enzalutamide to abiraterone
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Time to PSA progression; TTPP
Key secondary outcomes
Overall survival, radiographic progression-free survival, time to cytotoxic chemotherapy initiation, time to stage-up of ECOG performance status, time to opioid analgesic initiation, PSA response rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
enzalutamide 160mg
Interventions/Control_2
abiraterone 1000mg
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. Pathologically or cytologically confirmed castration-resistant prostate cancer defined as total testosterone <50 ng/dl and two consecutive PSA elevatoin with 1week interval and the PSA judged is at least 2ng/ml higher than nadir.
2. No previous cytotoxic intravenous systemic chemotherapy
3. >=20 years old
4. ECOG PS 0-2
5. Total bilirubin <=1.5xUpper Limit of Normal (ULN), aspartate transaminase <=2.5xULN (<=5.0xULN in patients with liver metasiasis), alanine transaminase <=2.5xULN (<=5.0xULN in patients with liver metasiasis), no ascites, and no hepatic encephalopathy
6. Serum creatinine <=2.0xULN
7. Life expectancy >3months
8. Obtained infromed consent with document
Key exclusion criteria
1. Allergy for enzalutamide, abiraterone, and prednisolone
2. Desire to bear children
3. Patients who were judged unfit for enrollment by physicians in charge
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Izumi |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
9208641
Address
13-1 Takaramachi Kanazawa Ishikawa Japan
TEL
076-265-2393
azuizu2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kouji |
| Middle name | |
| Last name | Izumi |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
9208641
Address
13-1 Takaramachi Kanazawa Ishikawa Japan
TEL
076-265-2393
Homepage URL
azuizu2003@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science, Department of Integrative Cancer Therapy and Urology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Graduate School of Medical Science, Department of Integrative Cancer Therapy and Urology
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
Institutional review board
Address
13-1 Takaramachi Kanazawa Ishikawa Japan
Tel
0762652019
azuizu2003@yahoo.co.jp
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
| 2014 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
203
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
Main results already published
Date of protocol fixation
| 2014 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2014 | Year | 10 | Month | 26 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018040
| 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 |
