UMIN-CTR Clinical Trial

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
Email	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
Email	takahashi.masayuki@tokushima-u.ac.jp

Sponsor
Institute	Department of Urology, Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004914