UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035375 |
|---|---|
| Receipt number | R000040303 |
| Scientific Title | Early conversion to cabazitaxel for castration-resistant prostate cancer |
| Date of disclosure of the study information | 2018/12/26 |
| Last modified on | 2018/12/26 23:14:34 |
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Basic information
Public title
Early conversion to cabazitaxel for castration-resistant prostate cancer
Acronym
ECOCAB
Scientific Title
Early conversion to cabazitaxel for castration-resistant prostate cancer
Scientific Title:Acronym
ECOCAB
Region
| Japan |
Condition
Condition
castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of early conversion to cabazitaxel for castration-resistant prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSA response rate
Key secondary outcomes
1) Overall survival
2) Progression-free survival
3) PSA progression-free survival
4) QOL assessment: FACT-P
5) Safety: CTCAE ver4.0
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cabazitaxel
Interventions/Control_2
docetaxel
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1. Pathologically confirmed prostate cancer with progression and serum testosterone level of <50 ng/dL during androgen deprivation therapy
2. After docetaxel treatment (docetaxel, predonisolone) of 4 cycles
3. PSA response rate of less than 50% and no radiographic progression
4. Age from 40 to 80 years old
5. Able to take oral medications
6. Life expectancy >6 months
7. ECOG PS 0-2
8. Preserved hematologic function within 4 weeks as follows;
a) WBC>=3000/mm3
b) Hb >=9g/dl
c) Plt >=75000/mm3
d) serum creatinine <=3.0 mg/dl
e) total bilirubin <=1.8mg/dl
f) aspartate aminotransferase <=90 IU/l
g) alanine aminotransferase <=100 IU/l
9. Obtained informed consent with document
Key exclusion criteria
1. No previous cabazitaxel treatment
2. Active concomitant malignancy in 3 years except for prostate cancer
3. Difficult to control severe complications except for malignancy
4. Seizure to be treated with anticonvulsant
5. Severe liver dysfunction
6. Allergy for cabazitaxel, docetaxel and predonisolone
7. Neither ability nor will to cooperate the study
8. Unfit for enrollment by physician in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoya Masumori |
Organization
Sapporo Medical University School of Medicine
Division name
Urology
Zip code
Address
S1, W16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
masumori@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohei Hashimoto |
Organization
Sapporo Medical University School of Medicine
Division name
Urology
Zip code
Address
S1, W16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
Homepage URL
hashimoto.kouhei@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 26 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040303
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
