UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015996 |
|---|---|
| Receipt number | R000018599 |
| Scientific Title | Investigation of clinical efficacy of Enzalutamide and its predictive factors in CRPC patients |
| Date of disclosure of the study information | 2014/12/23 |
| Last modified on | 2020/11/19 17:20:12 |
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Basic information
Public title
Investigation of clinical efficacy of Enzalutamide and its predictive factors in CRPC patients
Acronym
Efficacy of Enzalutamide in CRPC patients
Scientific Title
Investigation of clinical efficacy of Enzalutamide and its predictive factors in CRPC patients
Scientific Title:Acronym
Efficacy of Enzalutamide in CRPC patients
Region
| Japan |
Condition
Condition
castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical efficacy of Enzalutamide and its predictive factors on disease progression after the administration of bicalutamide
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SMAC, CBC, serum PSA, cytokines, androgens, Lipid metabolism. Bone markers, QoL assessment
PSA-PFS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with Enzalutamide
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male
Key inclusion criteria
1)CRPC patients undergoing ADT with GnRH antagonists,agonist or bilateral orchiectomy
2) Testosterone levels of less than 50 ng/dL
3) 25% increase in PSA from nadir (and by 2 ng/mL) which is confirmed 4 weeks later
4) ECOG PS 0-2
5) Signed written informed consent
Key exclusion criteria
1) Severe cardiac function disorders, hepatic function disorders, renal function disorders, infectious disease or hematopoietic disorders
2) Hypersensitivity to study medication
3) History of seizure or any condition that may predispose to seizure
4) Age <20 years
5) History of treatment with Enzalutamide, Abiraterone or chemotherapy
6) Patients whom the investigator judges inappropriate for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Oya |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL
03-5363-3825
moto-oya@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeo Kosaka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL
03-5363-3825
Homepage URL
takemduro@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharmaceutical Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 12 | Month | 23 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018599
