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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015529
Receipt No. 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 2015/04/28

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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 Enable Study
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 Enable Study
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
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
Middle name
Last name Kouji Izumi
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrative Cancer Therapy and Urology
Zip code
Address 13-1 Takaramachi Kanazawa Ishikawa Japan
TEL 076-265-2393
Email azuizu2003@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouji Izumi
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrative Cancer Therapy and Urology
Zip code
Address 13-1 Takaramachi Kanazawa Ishikawa Japan
TEL 076-265-2393
Homepage URL
Email azuizu2003@yahoo.co.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science, Department of Integrative Cancer Therapy and Urology
Institute
Department

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
Address
Tel
Email

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 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
2014 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
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
2015 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018040

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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