UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Androgen-deprivation therapy plus abiraterone and prednisolone vs combined androgen blockade for high-risk, metastatic, castration-sensitive prostate cancer : A randomized controlled trial
Title of the study (Brief title)	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	Kawamura Norihiko
Organization	Osaka General Medical Center
Division name	Department of Urology
Address	3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka, Osaka
TEL	06-6692-1201
Email	norijilmur@gmail.com

Public contact
Name of contact person	Kawamura Norihiko
Organization	Osaka General Medical Center
Division name	Department of Urology
Address	3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka, Osaka
TEL	06-6692-1201
Homepage URL
Email	norijilmur@gmail.com

Sponsor
Institute	Osaka General Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 02 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040931