UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014243 |
|---|---|
| Receipt number | R000016585 |
| Scientific Title | Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer. |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2020/12/15 09:54:55 |
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Basic information
Public title
Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.
Acronym
Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.(KYUCOG-1401)
Scientific Title
Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.
Scientific Title:Acronym
Randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicalutamide for patients with metastatic prostate cancer.(KYUCOG-1401)
Region
| Japan |
Condition
Condition
metastatic prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate a clinical response of the GnRH agonist CAB therapy against GnRH antagonist monotherapy for metastatic prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
PSA Progression Free Survival
Key secondary outcomes
1. Time to CAB Treatment Failure
(TTF in the case of deferred CAB therapy in antagonist monotherapy group)
2. Overall Survival
3. Progression Free Survival in image diagnosis
4. Radiographic Progression Free Survival
5. Change of PSA
6. Effect on hormone dynamics
7. Change of bone metabolic markers
8. Effect on lipid metabolism
9. Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Degarelix 240mg, sc at day 1.
Degarelix 240mg, sc every 4 weeks.
Bicalutamide 80mg daily(as deferred CAB therapy in the case of PSA recurrence)
Interventions/Control_2
Leuprorelin or goserelin: subcutaneous injection (according to usage and administration of package insert). Bicalutamide 80mg daily.
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. Histopathological confirmed prostate cancer patients.
2. Patients with metastatic prostate cancer (Stage D1,D2).
3. Patients' survival is expected more than six months.
4. Patients with written informed consent.
Key exclusion criteria
1. Patients with history of treatment or under treatment on prostate cancer.
2. Patients with active double cancer. Patients with history of malignant tumor within the past 5 years are regarded as having active double cancer. The basal cell carcinoma that radical treatment was taken or superficial squamous cell carcinoma are not included in active double cancer.)
3. Patients with less than 20 years of age on the enrollment day.
4. Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Naito |
Organization
HARASANSHIN Hospital
Division name
Urology
Zip code
8120033
Address
1-8 Taihakumachi ,Hakata-ku,Fukuoka, Japan 812-0033
TEL
092-291-3434
naito@harasanshin.or.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yokomizo |
Organization
HARASANSHIN Hospital
Division name
Urology
Zip code
8120033
Address
1-8 Taihakumachi ,Hakata-ku,Fukuoka, Japan 812-0033
TEL
092-291-3434
Homepage URL
yokoa@harasanshin.or.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Network Fukuoka Certified Review Board
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka.
Tel
092-643-7171
mail@crnfukuoka.jp
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
九州大学病院（福岡県）
長崎大学病院（長崎県）
山口大学病院（山口県）
宮崎大学病院（宮崎県）
鹿児島大学病院（鹿児島県）
他大学関連施設
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 12 | 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
200
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 | 06 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016585
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