UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019855 |
|---|---|
| Receipt number | R000022798 |
| Scientific Title | A study to Determine Enzalutamide Long-term safety and efficacy after anti-androgen therapy for CRPC. |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2015/11/18 23:27:10 |
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Basic information
Public title
A study to Determine Enzalutamide Long-term safety and efficacy after anti-androgen therapy for CRPC.
Acronym
A study to Determine Enzalutamide Long-term safety and efficacy after anti-androgen therapy for CRPC. (DELC study)
Scientific Title
A study to Determine Enzalutamide Long-term safety and efficacy after anti-androgen therapy for CRPC.
Scientific Title:Acronym
A study to Determine Enzalutamide Long-term safety and efficacy after anti-androgen therapy for CRPC. (DELC study)
Region
| Japan |
Condition
Condition
Castration resistant prostate cancer (CRPC)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this prospective observational study is to investigate the efficacy and safety of enzalutamide after alternating anti-androgen therapy in patients with castration resistant prostate cancer (CRPC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival (OS)
Key secondary outcomes
1)PSA-PFS (prostate specific antigen)-(progression-free survival)
2) Progression-free survival (PFS)
3) Time to treatment failure (TTTF)
4) Time-to-PSA-progression (TTPP)
5) PSA response rate
6)Time to first symptomatic skeletal event (TTFS) (or Time to First SSE)
7) medication adherence
8) Safety assessment by the incidence and severity of adverse events as assessed by Japanese version of CTCAE v4.00)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male
Key inclusion criteria
1)Patients with histologically or cytologically confirmed prostate cancer.
2)Patients who are receiving or received continuous androgen deprivation therapy using both gonadotropin-releasing hormone(GnRH)agonist and antagonist(medical castration), or both testicles removal by surgery (surgical castration).
3)Castration resistant prostate cancer(CRPC) patients who are observed disease progression after castration treatment and implied the treatment resistant.
4)CRPC patients who conducted anti-androgen alternating therapy as shown below 1) and are observed one or more of disease progression shown as below 2)during or after the therapy and decided to administer enzalutamide.
Note 1)anti-androgen alternating therapy is defined as the therapy of flutamide administration after bicalutamide.
Note 2)Disease progression criteria during or after anti-androgen alternating therapy
1. PSA progression during or after anti-androgen alternating therapy: PSA increased more than 25% compare to the lowest test results after initial dose of anti-androgen alternating therapy(flutamide)and the increasing is more than 2 ng/ml.
2. Confirmed disease progression of soft tissue lesion defined as RECIST v1.1.
3.Confirmed disease progression of bone lesion defined as 2 or more of new appearance of bone lesion on bone scintigraphy.
5)Patients with the Eastern Cooperative Oncology Group(ECOG)performance status 0-2
6)Patients who have signed written informed consent to participate in this study
Key exclusion criteria
1)Patients who is administering or have administration history of enzalutamide, abiraterone, docetaxel or cabazitaxel
2)Patients with history of seizure or predisposing disease of seizure
3)Patients with severe liver dysfunction
4)Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
5)Patients who considered to be inappropriate for the study participation by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Nonomura |
Organization
Osaka University Graduate School
Of Medicine
Division name
Department of Urology
Zip code
Address
2-2, Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3531
jimu@uro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohide Uemura |
Organization
Osaka University Graduate School Of Medicine
Division name
Department of Urology
Zip code
Address
2-2, Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3531
Homepage URL
jimu@uro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School Of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
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
| 2015 | Year | 11 | Month | 18 | 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
| 2015 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2015 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022798
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