UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009181 |
|---|---|
| Receipt number | 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 19:37:57 |
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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
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
None
Name of secondary funder(s)
None
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010755
