UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012967 |
|---|---|
| Receipt number | R000015153 |
| Scientific Title | Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer |
| Date of disclosure of the study information | 2014/01/31 |
| Last modified on | 2021/03/05 15:08:04 |
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Basic information
Public title
Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Acronym
Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Scientific Title
Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Scientific Title:Acronym
Randomized control study to evaluate the efficacy of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Denosumab versus zoledronic acid for treatment of bone metastases in men with prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical markers of bone turnover(serum NTx,BAP)
Key secondary outcomes
Serum PSA
Serum Ca
Skeltal related events
Progression-free survival
Over all survival
Adverse events
QOL
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive 120 mg denosumab every 4 week, and Combined Androgen Blockade (CAB) with LH-RH analog or surgical castration, and anti-androgen.
Interventions/Control_2
Patients receive 4 mg zoledronic acid every 4 week, and Combined Androgen Blockade (CAB) with LH-RH analog or surgical castration, and anti-androgen.
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1.Performance status 0-2 (ECOG)
2.Written informed consent
3.Histologically confirmed prostate cancer, existing radiographic evidence of at least one bone metastasis
4.Patients who satisfy the following
(a)WBC>=3000/mm3
(b)AST<=100 IU/L ,ALT<=100 IU/L, Serum creatinine<=2.0 mg/dl, Serum adjusted calcium8.0-10.0mg/dl
Key exclusion criteria
1.Patients who had prior bisphosphonate
2.Patients who are on hemodialysis
3.Patients who are treated with chemotherapy
4.Patients with poorly controlled hepatic disorder or renal dysfunction or diabetes
5.Patients who are receiving or planning treatment of tooth extraction or dental implant for oral infeciton
6.Patients who considered inappropriate for this trial by physicians
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Komaru |
Organization
Chiba Cancer Center
Division name
Urology
Zip code
Address
666-2 Nitona,Chuo-ku,Chiba,260-8717,Japan
TEL
043-264-5431
akomaru@chiba-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Komaru |
Organization
Chiba Cancer Center
Division name
Urology
Zip code
Address
666-2 Nitona,Chuo-ku,Chiba,260-8717,Japan
TEL
043-264-5431
Homepage URL
akomaru@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
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
千葉県がんセンター(千葉県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015153
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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