UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized, open-label, phase three study comparing flutamide and abiraterone in patients with advanced prostate cancer after failure of first combined androgen blockade therapy.
Title of the study (Brief title)	Randomized, open-label, phase three study comparing flutamide and abiraterone in patients with advanced prostate cancer after failure of first combined androgen blockade therapy.
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare treatment with flutamide and abiraterone in patients with advanced prostate cancer after failure of first combined androgen blockade therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biochemical-free Survival rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
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	Patients assigned to receive flutamide therapy.
Interventions/Control_2	Patients assigned to receive abiraterone therapy.
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	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male
Key inclusion criteria	Advanced prostate cancer patients after failure of first combined androgen blockade therapy. Eastern Cooperative Oncology Group performance status of 0 to 2.
Key exclusion criteria	Patients who have other active cancer, infection diseases or glaucome are excluded.
Target sample size	40

Research contact person
Name of lead principal investigator	Noriyasu Kawai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Address	1, Kawasumi,Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-853-8266
Email	n-kawai@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Ryosuke Ando
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Address	1, Kawasumi,Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-853-8266
Homepage URL
Email	ryo@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	Nagoya City University Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 02 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 02 Month 09 Day
Anticipated trial start date	2015 Year 02 Month 26 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	2015 Year 02 Month 24 Day
Last modified on	2017 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019292