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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013151
Receipt No. R000015335
Scientific Title An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Date of disclosure of the study information 2014/02/13
Last modified on 2014/02/13

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Basic information
Public title An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Acronym An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Scientific Title An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Scientific Title:Acronym An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Region
Japan

Condition
Condition Prostatic Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze/confirm the possibility of novel standard therapy by comparing the laboratory value changes at early stage after GnRH antagonist/antiandrogen combination therapy with those after GnRH agonist/antiandrogen combination in prostate cancer patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of patients whose serum PSA at day 28 are 90% or less compared to those before administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 Degarelix + bicalutamide
Interventions/Control_2 LHRH agonist + bicalutamide
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 Male patients with histologically proven prostate cancer (all stages)
Key exclusion criteria Patient who were inappropriate for this study judged by medical doctor
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Nonomura
Organization Osaka University Graduate School of Medicine
Division name Department of Organ Specific Regulation (Urology)
Zip code
Address 2-2 yamada-oka, Suita, Osaka
TEL 81668793531
Email nono@uro.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohide Uemura
Organization Osaka University Graduate School of Medicine
Division name Department of Organ Specific Regulation (Urology)
Zip code
Address 2-2 yamada-oka, Suita, Osaka
TEL 81668793531
Homepage URL
Email uemura@uro.med.osaka-u.ac.jp

Sponsor
Institute The Supporting Center for Clinical Research and Education
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
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
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
2014 Year 02 Month 13 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
2014 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 04 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
2014 Year 02 Month 13 Day
Last modified on
2014 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015335

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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