UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022102 |
|---|---|
| Receipt number | R000025463 |
| Scientific Title | Randomized control trial of Abiraterone and Enzalutamide for castration resistant prostate cancer patients. |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2020/05/01 17:44:49 |
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Basic information
Public title
Randomized control trial of Abiraterone and Enzalutamide for castration resistant prostate cancer patients.
Acronym
Abenza trial
Scientific Title
Randomized control trial of Abiraterone and Enzalutamide for castration resistant prostate cancer patients.
Scientific Title:Acronym
Abenza trial
Region
| Japan |
Condition
Condition
Castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospective randomized trial was conducted to compare the usefulness of abiraterone and enzalutamide for castration resistant prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
PSA response rate in each group of abiraterone and enzalutamide as primary therapy
Key secondary outcomes
1. PSA or radiographic progression free rate in each group of abiraterone and enzalutamide as primary therapy
2. PSA response rate in each group of abiraterone and enzalutamide as primary therapy
3. PSA or radiographic progression free rate in each group of abiraterone and enzalutamide as whole therapy after cross-over
4. Time until introduction of chemotherapy or best supportive care (BSC)
5. Overall survival time
6. QOL analysis by FACT P
7. Adverse events in each group of abiraterone and enzalutamide
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Abiraterone
Interventions/Control_2
Enzalutamide
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
| Not applicable |
Age-upper limit
| 85 | years-old | > |
Gender
Male
Key inclusion criteria
1. Castration resistant prostate cancer patients with or without metastasis after at least one kind of anti-androgen therapy who are unfit for docetaxel chemotherapy.
2. PSA less than 5ng/ml
3. Under 85 years old
4. ECOG PS is 0-2 and at least 3 months of survival is expected.
5. Appropriate visceral function
WBC > 3000/mm3 or Neutrophils > 1500/mm3
AST, ALT <upper limit of normal range X 1.5
sCr < upper limit of normal range X 1.5
6. Written informed consent is obtained.
Key exclusion criteria
Not specifically defined.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Hara |
Organization
Wakayama Medical University
Division name
Department of Urology
Zip code
641-8509
Address
811-1 KImiidera, Wakayama City, Wakayama Prefecture
TEL
073-441-0637
hara@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Hara |
Organization
Wakayama Medical University
Division name
Department of Urology
Zip code
641-8509
Address
811-1 KImiidera, Wakayama City, Wakayama Prefecture
TEL
073-441-0637
Homepage URL
hara@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Urology
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology
Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Wakayama Medical University
Address
811-1 Kimiidera, Wakayama city
Tel
073-441-0714
wa-rinri@wakayama-med.ac.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
和歌山県立医科大学付属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2027 | 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
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025463
| Research Plan | |
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| 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 |
