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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036159
Receipt No. R000041165
Scientific Title Efficacy of pre operative Tegafur/Uracil and Degarelix combination therapy for high risk prostate cancer
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/11

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Basic information
Public title Efficacy of pre operative Tegafur/Uracil and Degarelix combination therapy for high risk prostate cancer
Acronym Efficacy of pre operative Tegafur/Uracil and Degarelix combination therapy for high risk prostate cancer
Scientific Title Efficacy of pre operative Tegafur/Uracil and Degarelix combination therapy for high risk prostate cancer
Scientific Title:Acronym Efficacy of pre operative Tegafur/Uracil and Degarelix combination therapy for high risk prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 The efficacy of preoperative hormonal therapy on high-risk prostate cancer is limited. In this study we will investigate whether prognosis can be improved by combining tegafur / uracil (UFT) and degarelix before radical prostatectomy for high-risk prostate cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes survival rate after radical prostatectomy
Key secondary outcomes Adverse event

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This study is single arm study. Control group is historical cohort.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria High risk prostate cancer patients who will be received radical prostatectomy.
Key exclusion criteria Patient who is difficult to obtain his consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Taku
Middle name
Last name Kato
Organization Gifu University Graduate School of Medicine
Division name Department of Urology
Zip code 5011194
Address 1-1 Yanagido Gifu City
TEL 0582306338
Email takukato@gifu-u.ac.jp

Public contact
Name of contact person
1st name Taku
Middle name
Last name Kato
Organization Gifu University Graduate School of Medicine
Division name Department of Urology
Zip code 5011194
Address 1-1 Yanagido Gifu City
TEL 0582306338
Homepage URL
Email urojim@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Department of Medicine Gifu University
Address 1-1 Yanagido, Gifu City
Tel 0582306000
Email rinri@gifu-u.ac.jp

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
2019 Year 04 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
2019 Year 03 Month 06 Day
Date of IRB
2019 Year 03 Month 06 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 11 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041165

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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