UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004203 |
|---|---|
| Receipt number | R000004914 |
| Scientific Title | Clinical Trial evaluating the correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in patients with prostate cancer who relapsed after maximum androgen blockade |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2019/09/21 14:22:16 |
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Basic information
Public title
Clinical Trial evaluating the correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in patients with prostate cancer who relapsed after maximum androgen blockade
Acronym
The correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in castration-resistant prostate cancer
Scientific Title
Clinical Trial evaluating the correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in patients with prostate cancer who relapsed after maximum androgen blockade
Scientific Title:Acronym
The correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in castration-resistant prostate cancer
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation of clinical efficacy of alternative antiandrogens and UFT therapy with mRNA expression of enzymes related to 5-FU metabolism in patients with prostate cancer who relapsed after maximum androgen blockade
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1.PSA response
2.PSA failure free survival
Key secondary outcomes
Safety
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
adding UFT to alternative antiandrogen for patients who relapsed after maximum androgen blockade
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1.pathologicaly confirmed prostate cancer
2.relapsed after maximum androgen blockade
3.AWS is confirmed
4.PS(ECOG)0-2
5.life expectancy of at least 3 month
6.general condition is enough and to satisfy the next condition
Hb:more than 10.0g/dL
WBC:more than 3.000/mm3 and below 12.000/mm3
NEU:more than 2.000/mm3
PLT:more than 100.000/mm3
AST,ALT:under 100IU/L
T-Bil:under 1.5mg/dL
cre:under 1.5mg/dL
nomal ECG
7.specimens obtained by prostate biopsy are available
8.written informed concent
9.ingestion is possible
Key exclusion criteria
1.past history of radiotherapy or prostatectomy
2.past history of allergic reactions
3.use phenytoin
4.contraindication of UFT
5.active infection
6.serious complications
7.other cancer requiring treatment
8.judged inappropriate for the clinical trial by doctor
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiro-omi Kanayama |
Organization
Institute of Health Biosciences, The University of Tokushima Graduate School
Division name
Department of Urology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7159
kanayama.hiroomi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Takahashi |
Organization
Institute of Health Biosciences, The University of Tokushima Graduate School
Division name
Department of Urology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7159
Homepage URL
takahashi.masayuki@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Urology, Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | 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
| 2010 | Year | 09 | Month | 14 | Day |
Last modified on
| 2019 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004914
