UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016617
Receipt number R000019292
Scientific 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.
Date of disclosure of the study information 2015/02/25
Last modified on 2017/07/17 11:09:11

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Basic information

Public 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.

Acronym

Randomized, open-label, phase three study comparing flutamide and abiraterone in patients with advanced prostate cancer after failure of first combined androgen blockade therapy.

Scientific 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.

Scientific Title:Acronym

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

1st name
Middle name
Last name Noriyasu Kawai

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Nephro-urology

Zip code


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

1st name
Middle name
Last name Ryosuke Ando

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Nephro-urology

Zip code


Address

1, Kawasumi,Mizuho-cho, Mizuho-ku, Nagoya, Japan

TEL

052-853-8266

Homepage URL


Email

ryo@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



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)



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

2015 Year 02 Month 25 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

Enrolling by invitation

Date of protocol fixation

2015 Year 02 Month 09 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019292


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name