UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Early conversion to cabazitaxel for castration-resistant prostate cancer
Title of the study (Brief title)	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	Naoya Masumori
Organization	Sapporo Medical University School of Medicine
Division name	Urology
Address	S1, W16, Chuo-ku, Sapporo 060-8543, Japan
TEL	011-611-2111
Email	masumori@sapmed.ac.jp

Public contact
Name of contact person	Kohei Hashimoto
Organization	Sapporo Medical University School of Medicine
Division name	Urology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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