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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009181
Receipt No. R000010755
Scientific Title A multi-center randomized phase II study to evaluate the combination therapy of substitution of antiandrogens and tegafur-uracil for castration resistant prostate cancer
Date of disclosure of the study information 2012/10/26
Last modified on 2012/10/24

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Basic information
Public title A multi-center randomized phase II study to evaluate the combination therapy of substitution of antiandrogens and tegafur-uracil for castration resistant prostate cancer
Acronym The combination therapy of substitution of antiandrogens and tegafur-uracil
Scientific Title A multi-center randomized phase II study to evaluate the combination therapy of substitution of antiandrogens and tegafur-uracil for castration resistant prostate cancer
Scientific Title:Acronym The combination therapy of substitution of antiandrogens and tegafur-uracil
Region
Japan

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

Objectives
Narrative objectives1 We examine effectiveness and safety of the combination therapy of substitution of antiandrogen or adding antiandrogen to LH-RH analogue with tegafur-uracil as compared to substitution of antiandrogen or adding antiandrogen to LH-RH analogue alone. We also examine clinical significance of mRNA expression levels of key enzymes which are involved with 5-FU metabolism as a predictive factor for this combination therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes PSA response rate
Key secondary outcomes Time to PSA progression, survival, adverse events, the correlation of mRNA expression of enzymes that are involved with 5-FU with anti-tumor effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A: to add antiandrogen or substitute antiandrogen until disease progression
Interventions/Control_2 Group B: to combine adding antiandrogen or substitution of antiandrogen with tegafur-uracil until disease progression
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 LH-RH analogue/castration/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 4,000/mm3 and below 12,000/mm3
Neutrophil count:more than 2,000/mm3
Platelet:more than 100,000/mm3
AST,ALT:under 100 IU/L
T-Bilirubin:under 1.5 mg/dL
creatinine:under 1.5 mg/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 tegafur-uracil
5.active infection
6.serious complications
7.other cancer requiring treatment
8.judged inappropriate for the clinical trial by doctor
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroomi Kanayama
Organization Institute of Health Biosciences, The University of Tokushima Graduate School
Division name Department of Urology
Zip code
Address Department of Urology
TEL 088-633-7159
Email

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 None
Name of secondary funder(s) None

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 阿南医師会中央病院(徳島県)、麻植協同病院(徳島県)、亀井病院(徳島県)、健康保険鳴門病院(徳島県)、つるぎ町立半田病院(徳島県)、徳島県立中央病院(徳島県)、徳島県立三好病院(徳島県)、徳島市民病院(徳島県)、徳島大学病院(徳島県)、さぬき市民病院(香川県)、大樹会回生病院(香川県)、高松赤十字病院(香川県)、独立行政法人国立病院機構善通寺病院(香川県)、屋島総合病院(香川県)、愛媛県立新居浜病院(愛媛県)、高知赤十字病院(高知県)、高知高須病院(香川県)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Fifty-two patients were enrolled in this study.  Median age was 77 (47-92) years old.  PSA response rate in group B (61.5%) tended to be higher than that in group A (34.6%) (p=0.0950).  Group B (15.9 months) had significantly longer median time to PSA progression (TTP) than group A (6.4 months) (p=0.0137).  In group B, patients with low TS (81.8%) tended to have higher PSA response rate than those with high TS (46.2%).  In addition, among the patients with low TS, group B have shown significantly longer TTP than group A (p=0.0175).  There were no severe AEs in both treatment groups.
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 Completed
Date of protocol fixation
2005 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2010 Year 09 Month 30 Day
Date of closure to data entry
2012 Year 10 Month 24 Day
Date trial data considered complete
2012 Year 10 Month 24 Day
Date analysis concluded
2012 Year 10 Month 24 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 24 Day
Last modified on
2012 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010755

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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