UMIN-CTR Clinical Trial

Basic information
Public title	Special Drug Use-Results Survey for ZYTIGA Tablets 250 mg (Long-term Use)
Acronym	Special Drug Use-Results Survey for ZYTIGA Tablets 250 mg (Long-term Use)
Scientific Title	Special Drug Use-Results Survey for ZYTIGA Tablets 250 mg (Long-term Use)
Scientific Title:Acronym	Special Drug Use-Results Survey for ZYTIGA Tablets 250 mg (Long-term Use)
Region	Japan

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

Objectives
Narrative objectives1	To assess the long-term safety and efficacy of ZYTIGA Tablets 250 mg in patients with castration-resistant prostate cancer under actual use conditions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety(Adverse Drug Reaction) Effectiveness(PSA Response rate)
Key secondary outcomes	Effectiveness(Overall survival)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male
Key inclusion criteria	CRPC patients who are treated with ZYTIGA for the first time
Key exclusion criteria	NA
Target sample size	420

Research contact person
Name of lead principal investigator	1st name Toshiya Middle name Last name Kato
Organization	Janssen Pharmaceutical K.K.
Division name	Safety Risk Management Dept.
Zip code	101065
Address	5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL	03-4411-5478
Email	tkato1@its.jnj.com

Public contact
Name of contact person	1st name Sayuri Middle name Last name Harada
Organization	Janssen Pharmaceutical K.K.
Division name	Safety Risk Management Dept.
Zip code	101065
Address	5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL	03-4411-5874
Homepage URL
Email	SHarada8@its.jnj.com

Sponsor
Institute	Janssen Pharmaceutical K.K.
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Janssen Pharmaceutical K.K.
Address	5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
Tel	03-4411-5874
Email	SHarada8@its.jnj.com

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 12 Month 15 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	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
Date of IRB	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 16 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 10 Month 09 Day
Date analysis concluded

Other
Other related information	Prospective study

Management information
Registered date	2014 Year 12 Month 10 Day
Last modified on	2020 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018504