UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013668 |
|---|---|
| Receipt number | R000014898 |
| Scientific Title | Deferred combined androgen blockade therapy using antiandrogen in metastatic prostate cancer patients treated with GnRH antagonist, degarelix |
| Date of disclosure of the study information | 2014/04/08 |
| Last modified on | 2019/01/28 17:19:19 |
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Basic information
Public title
Deferred combined androgen blockade therapy using antiandrogen in metastatic prostate cancer patients treated with GnRH antagonist, degarelix
Acronym
Deferred combined androgen blockade therapy using antiandrogen in metastatic prostate cancer patients treated with GnRH antagonist, degarelix
Scientific Title
Deferred combined androgen blockade therapy using antiandrogen in metastatic prostate cancer patients treated with GnRH antagonist, degarelix
Scientific Title:Acronym
Deferred combined androgen blockade therapy using antiandrogen in metastatic prostate cancer patients treated with GnRH antagonist, degarelix
Region
| Japan |
Condition
Condition
Metastatic prostate cancer (Untreated)
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of add-on therapy of antiandrogen (bicalutamide and flutamide) in patients with PSA failure metastatic prostate cancer who undergo degarelix monotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Biochemical recurrence is defined as a >=25% or >= 2ng/mL increase from minimum value in PSA which is lowered by degarelix monotherapy. After antiandrogen is initiated, the efficacy of those is considered.
Key secondary outcomes
Firstly bicalutamide will be administrated, then, in case of no efficacy or biochemical recurrence, flutamide will be administrated and efficacy of this therapy will be reevaluated. If flutamide shows no efficacy, this research will be discontinued.
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
Degarelix monotherapy.
Bicalutamide will be added in case of recurrence.
Bicalutamide will be replaced with Flutamide in case of second recurrence.
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 that histologically proven prostate can.
2)Patients that treatment of the prostate cancer haven't got before.
3)Patients that has metastasis(in the TNM classification N1 and M1).
4)Patients that duration of survival is anticipated more than six months.
5)Patients that an agreement of the participation in this study is provided in a document
Key exclusion criteria
1)Patients that correspond to the taboo of the use drug.
2)Patients that had orchidectomy before.
3)Patients younger than 20 years.
4)Active multiple cancer(synchronous multiple cancer/multifocal cancer and metachronous multiple cancer/multifocal cancer with disease free survival is within 5 years except for carcinoma in situ considered as healed or lesion equal to mucosal carcinoma)
5)Active infection requiring systemic therapy
6)Body temperature >=38 degrees Celsius at registration
7)Concomitant psychiatric disease or symptom
8)Continuous systemic steroids or immunosuppressive medication(oral or intravenous)
9)Considered as inadequate by the investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Oyama |
Organization
Saitama Medical University International Medical Center
Division name
Urooncology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4111
oyama@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Ishii |
Organization
Saitama Medical University International Medical Center
Division name
Clinical Research Support Center
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4111
Homepage URL
chikens@saitama-med.ac.jp
Sponsor or person
Institute
Department of Urooncology, Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Asteiias 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 | 04 | Month | 08 | 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 | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 08 | Day |
Last modified on
| 2019 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014898
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
