UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015265 |
|---|---|
| Receipt number | R000017730 |
| Scientific Title | The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients. |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2019/12/27 19:26:00 |
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Basic information
Public title
The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.
Acronym
The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.
Scientific Title
The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.
Scientific Title:Acronym
The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the transition of PSA, total prostate volume, serum testosterone, luteinizing hormone (LH), follicle- stimulating hormone (FSH), BAP, IPSS by switching from GnRH agonist to antagonist for the treatment of CRPC patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSA response.
Key secondary outcomes
Total prostate volume, Serum testosterone, LH, FSH, BAP, IPSS, safety (CTCAE ver. 4.0), QOL
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1.pathologically diagnosed as prostate cancer. (neuroendocrine cancer or small cell cancer were excluded.)
2.gnrH agonist resistance.
3.adminstration of gnrh agonist during the study, in case the patients have not received surgical castration.
4.serum testosterone < 0.50 ng/ml
5.serum psa > 2.5 ng/ml
6.If zoledronic acid hydrate is administered, there is no change of dose at least four weeks before dosage of degarelix.
7.psa is greater than 2.5 ng/ml within six months. the rise of psa has to be at least 50% over nadir and has to be confirmed by a second psa at least two weeks later.
8.as for the patients who had received systemic chemotherapy, patients received no more than two regimens including at least one course of docetaxel therapy.
9.performance status(ps; eastern co-operative oncology group) 0-1.(the patients whose ps are 2 due to bone pain are permitted.)
10.age more than 17
11.written informed consent was obtained.
12.the patients can prevent pregnancy by appropriate methods (a condom or a pessary) from the start of study to at least three months after the last dose.
Key exclusion criteria
1. receive radiation therapy within twelve weeks before dosage of degarelix.
2. when the investigator thinks the patient is ineligible.
3. other systemic disease which is severe or uncontrollable.
4. severe allergy to degarelix.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Sakamoto |
Organization
Chiba University Hospital
Division name
Urology
Zip code
Address
1-8-1 inohana cho, Chuo-ku, Chiba-city, Chiba Prf. Japan
TEL
043-226-2134
rbatbat1@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Sakamoto |
Organization
Chiba University Hospital
Division name
Urology
Zip code
Address
1-8-1 inohana cho, Chuo-ku, Chiba-city, Chiba Prf. Japan
TEL
043-226-2134
Homepage URL
rbatbat1@chiba-u.jp
Sponsor or person
Institute
Department of Urology, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
AstraZeneca K.K.
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 | 10 | Month | 01 | 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 | 09 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the transition of PSA, total prostate volume, serum testosterone, luteinizing hormone (LH), follicle- stimulating hormone (FSH), BAP, IPSS by switching from GnRH agonist to antagonist for the treatment of CRPC patients.
Management information
Registered date
| 2014 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017730
