UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035933 |
|---|---|
| Receipt number | R000040931 |
| Scientific Title | Androgen-deprivation therapy plus abiraterone and prednisolone vs combined androgen blockade for high-risk, metastatic, castration-sensitive prostate cancer : A randomized controlled trial |
| Date of disclosure of the study information | 2019/02/20 |
| Last modified on | 2019/02/19 13:59:30 |
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Basic information
Public title
Androgen-deprivation therapy plus abiraterone and prednisolone vs combined androgen blockade for high-risk, metastatic, castration-sensitive prostate cancer : A randomized controlled trial
Acronym
Androgen-deprivation therapy plus abiraterone and prednisolone vs combined androgen blockade for high-risk, metastatic, castration-sensitive prostate cancer : A randomized controlled trial
Scientific Title
Androgen-deprivation therapy plus abiraterone and prednisolone vs combined androgen blockade for high-risk, metastatic, castration-sensitive prostate cancer : A randomized controlled trial
Scientific Title:Acronym
Androgen-deprivation therapy plus abiraterone and prednisolone vs combined androgen blockade for high-risk, metastatic, castration-sensitive prostate cancer : A randomized controlled trial
Region
| Japan |
Condition
Condition
high-risk, metastatic, castration-sensitive prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the efficacy of Androgen-deprivation therapy plus abiraterone and prednisolone vs combined androgen blockade for high-risk, metastatic, castration-sensitive prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time to biochemical recurrence (prostate specific antigen failure)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Androgen-deprivation therapy plus abiraterone and prednisolone
Interventions/Control_2
combined androgen blockade
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
patients are required to have at least two of the three following high-risk factors associated with poor prognosis: a Gleason score of 8 or more, at least three bone metastatic lesions, and the presence of measurable visceral metastasis.
Key exclusion criteria
1. Cases with no prostate biopsy
2. Cases with other cancers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawamura Norihiko |
Organization
Osaka General Medical Center
Division name
Department of Urology
Zip code
Address
3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka, Osaka
TEL
06-6692-1201
norijilmur@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kawamura Norihiko |
Organization
Osaka General Medical Center
Division name
Department of Urology
Zip code
Address
3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka, Osaka
TEL
06-6692-1201
Homepage URL
norijilmur@gmail.com
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2019 | Year | 02 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 06 | 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
| 2019 | Year | 02 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040931
