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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022102
Receipt No. 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

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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
Email 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
Email hara@wakayama-med.ac.jp

Sponsor
Institute Department of Urology
Wakayama Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025463

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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