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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027795
Receipt No. R000029208
Scientific Title The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer.
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/17

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Basic information
Public title The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer.
Acronym The efficacy of Abirateron and Dutasteride for CRPC.
Scientific Title The phaseII study of the efficacy of Abirateron acetate and Dutasteride therapy for castration resistant prostate cancer.
Scientific Title:Acronym The efficacy of Abirateron and Dutasteride for CRPC.
Region
Japan

Condition
Condition castration resistant prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effect and safety of androgen synthesis inhibition with abiraterone and dutasteride for the patients with castration resistant prostate cancer and benign prostate hyperplasia before the therapy of Docetaxel.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the rate of patients with over fifty percent reduction in PSA
Key secondary outcomes Time-to-treatment failure

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients is treated with abiraterone (1,000 mg daily) and prednisone (5 mg daily) for two 4-week cycles. After this time, dutasteride (0.5 mg daily) is added for 12 weeks. Patients continue on the three-drug regimen until study withdrawal or radiographic disease progression.
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
50 years-old <=
Age-upper limit
90 years-old >
Gender Male
Key inclusion criteria 1)advanced prostate cancer (>stage III) with androgen deprivation therapy
2)a serum total testosterone <50 ng/dL
3)PSA progression as defined by the Prostate Cancer Clinical Trials Working Group
4)patients with benign prostate hyperplasia (IPSS>9)
5)
Hematologic and laboratory criteria including
White blood cell >3,000/mm3
Hemoglobin>8.0 g/dL
Platelet count>100000/mm3
aspartate aminotransferase (AST) <100 IU/L
alanine aminotransferase (ALT) <100 IU/L
Serum creatinine <1.5 mg/dL
patients provide written informed consent
Key exclusion criteria 1)Patients took 5alpha-reductase inhibitors previously
2)AST >101 IU/L or ALT>101 IU/L or Child-Pugh score C
3)HbA1c > 10%
4)serum potassium < 3.5 mEq/l
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyasu Matsuyama
Organization Yamaguchi Graduate School of Medicine
Division name Urology
Zip code
Address 1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
TEL 0836-22-2275
Email hidde@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Kawai
Organization Yamaguchi Graduate School of Medicine
Division name Urology
Zip code
Address 1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
TEL 0836-22-2275
Homepage URL
Email yoshipisa23@yahoo.co.jp

Sponsor
Institute Department od Urology, Yamaguchi Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Non profit foundation
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
2017 Year 07 Month 01 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
2017 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 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
2017 Year 06 Month 17 Day
Last modified on
2017 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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