UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002792 |
|---|---|
| Receipt number | R000003365 |
| Scientific Title | Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status. |
| Date of disclosure of the study information | 2009/11/26 |
| Last modified on | 2009/11/20 14:00:44 |
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Basic information
Public title
Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Acronym
Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Scientific Title
Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Scientific Title:Acronym
Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Region
| Japan |
Condition
Condition
Prostate cancer with bone metastasis
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
To examine bone marker (serum NTx) to assess judgment of the efficacy at early treatment and prognosis forecast.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of bone metastasis EOD grade
Key secondary outcomes
Change of SRE and BPI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hormon sensitive during zoledronic acid therapy
Interventions/Control_2
Hormon refractory after zoledronic acid therapy
Interventions/Control_3
Hormon refractory before zoledronic acid therapy
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
Patients of prostate cancer with bone metastasis
Key exclusion criteria
1.History of hypersensitivity for zoledronic acid or other bisphosphonate
2.Renal dysfunction(serum creatinine more than 3.0mg/dL)
3.Active concomititant malignancy
4.Severe coexisting disease
5.Invasive dental treatment within 3 months
6.Other bisphosphonate therapy for injection within 6 months
7.Not suitable for this trial
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Higashihara |
Organization
Kyorin University
Division name
Department of urology
Zip code
Address
6-20-2 Shinkawa,Mitaka-city, Tokyo
TEL
0422-47-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatsugu Okegawa |
Organization
Kyorin University
Division name
Department of urology
Zip code
Address
6-20-2 Shinkawa,Mitaka-city,Tokyo
TEL
0422-47-5511
Homepage URL
Sponsor or person
Institute
Tama Prostate cancer Bone metastasis Study group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
杏林大学医学部付属病院（東京都）、青梅市立病院（東京都）、河北総合病院（東京都）、公立阿伎留医療センター（東京都）、国立病院機構災害医療センター（東京都）、佐々総合病院（東京都）、多摩北部医療センター（東京都）、東京医科大学八王子医療センター（東京都）、都立府中病院（東京都）、西東京中央総合病院（東京都）、一橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2007 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 23 | Day |
Last modified on
| 2009 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003365
