UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009985 |
|---|---|
| Receipt number | R000011408 |
| Scientific Title | Study on parameters and efficacy of treatment with denosumab for bone metastases of prostate cancer |
| Date of disclosure of the study information | 2013/02/15 |
| Last modified on | 2013/02/06 22:50:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on parameters and efficacy of treatment with denosumab for bone metastases of prostate cancer
Acronym
Study on parameters and efficacy of treatment with denosumab for bone metastases of prostate cancer
Scientific Title
Study on parameters and efficacy of treatment with denosumab for bone metastases of prostate cancer
Scientific Title:Acronym
Study on parameters and efficacy of treatment with denosumab for bone metastases of prostate cancer
Region
| Japan |
Condition
Condition
Bone metastatic prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to find predictors of treatment effect with denosumab for prostate cancer bone metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of change of BSI and the bone turnover markers and PSA by the treatment
Key secondary outcomes
The correlation between rate of change of BSI and the bone turnover markers and PSA and skeletal related event by the treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
castration resistant prostate cancer (CRPC) with bone metastasis.
Key exclusion criteria
1)prostate cancer without bone metastasis
2)Prior treatment with surgery for bone metastasis before study start
3)Prior treatment with bisphosphonates before study start, and during treatment with zoledronic acid
4)Prior treatment with radiation therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensaku Seike |
Organization
Gifu University Hospital
Division name
Department of Urology
Zip code
Address
1-1 yanagido, Gifu
TEL
058-230-6000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensaku Seike |
Organization
Gifu University Hospital
Division name
Department of Urology
Zip code
Address
1-1 yanagido, Gifu
TEL
058-230-6000
Homepage URL
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Gifu University Hospital
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 | 02 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the correlation between BSI using bonenavi in bone scintigraphy and PSA and bone turnover marker and clinical symptoms and skeletal related events.
Management information
Registered date
| 2013 | Year | 02 | Month | 06 | Day |
Last modified on
| 2013 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011408
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
