UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011437 |
|---|---|
| Receipt number | R000013391 |
| Scientific Title | Deferred combined androgen blockade therapy using antiandrogen in hormone-refractory metastatic prostate cancer patients treated with Degarelix, GnRH antagonist |
| Date of disclosure of the study information | 2013/08/09 |
| Last modified on | 2013/08/09 20:13:14 |
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Basic information
Public title
Deferred combined androgen blockade therapy using antiandrogen in hormone-refractory metastatic prostate cancer patients treated with Degarelix, GnRH antagonist
Acronym
Deferred combined androgen blockade therapy using antiandrogen in hormone-refractory metastatic prostate cancer patients treated with Degarelix, GnRH antagonist
Scientific Title
Deferred combined androgen blockade therapy using antiandrogen in hormone-refractory metastatic prostate cancer patients treated with Degarelix, GnRH antagonist
Scientific Title:Acronym
Deferred combined androgen blockade therapy using antiandrogen in hormone-refractory metastatic prostate cancer patients treated with Degarelix, GnRH antagonist
Region
| Japan |
Condition
Condition
Bone metastatic prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the add-on effect of antiandrogen therapy in hormone - refractory bone metastatic prostate cancer patients treated with Degarelix
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum level of Prostate Specific Antigen (PSA) over time
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
Starting with Degarelix monotherapy.
Additive Bicalutamide will be used in case of PSA recurrence.
Bicalutamide will be replaced with Flutamide when second PSA recurrence occurs.
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) Histologically proven bone metastatic prostate cancer (adenocarcinoma).
2) A male patient in whom endocrine treatment is indicated.
Key exclusion criteria
Previous or present endocrine treatment for prostate cancer.
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 Organ Specific Regulation (Urology)
Zip code
Address
2-2 yamada-oka, Suita, Osaka
TEL
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 Organ Specific Regulation (Urology)
Zip code
Address
2-2 yamada-oka, Suita, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Organ Specific Regulation (Urology)
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2013 | Year | 08 | Month | 09 | 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
| 2013 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 13 | 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
| 2013 | Year | 08 | Month | 09 | Day |
Last modified on
| 2013 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013391
