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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035375
Receipt No. 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

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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
Email 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
Email hashimoto.kouhei@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040303

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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