UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036159 |
|---|---|
| Receipt number | 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 18:49:57 |
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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
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
urojim@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041165
