UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013290 |
|---|---|
| Receipt number | R000015001 |
| Scientific Title | Examination of the clinical meaning of the fever after zoledronic acid administration for therapy of bone metastasis arising from prostate cancer |
| Date of disclosure of the study information | 2014/02/26 |
| Last modified on | 2017/05/23 21:06:28 |
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Basic information
Public title
Examination of the clinical meaning of the fever after zoledronic acid administration for therapy of bone metastasis arising from prostate cancer
Acronym
Inspection of the fever after zoledronic acid administration for therapy of bone metastasis from prostate cancer
Scientific Title
Examination of the clinical meaning of the fever after zoledronic acid administration for therapy of bone metastasis arising from prostate cancer
Scientific Title:Acronym
Inspection of the fever after zoledronic acid administration for therapy of bone metastasis from prostate cancer
Region
| Japan |
Condition
Condition
Hormone therapy naive prostate cancer patient with bone metastasis
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We examine the clinical meaning of the fever after zoledronic acid administration combination with the primary hormone therapy for the prostate cancer patients with bone metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSA normalization rate (less than 4ng/ml) as of three months after start of the treatment
Key secondary outcomes
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
Combination of CAB therapy and zoledronic acid administration
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. Patient with prostate cancer defined by pathological examination
2. Patient with bone metastasis diagnosised by bone scan
3.Hormone therapy untreated patient
Key exclusion criteria
1. Patient received hormoe therapy previously
2. Patient plans the radiation therapy to the prostate with hormone therapy
3. Patient administered NSAIDs or corticosteroid
4. Patient with a severe renal function disorder
5. Patient that is continuing dental treatment such as the tooth extraction
6. Patient with severe psychosis
7. Patient with double cancer
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Miyaji |
Organization
Kawasaki Medical School
Division name
Department of urology
Zip code
Address
577 Matsushima, Kurashiki, Japan
TEL
086-462-1111
miyaji@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Miyaji |
Organization
Kawasaki Medical School
Division name
Department of urology
Zip code
Address
577 Matsushima, Kurashiki, Japan
TEL
086-462-1111
Homepage URL
miyaji@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Chugoku Shikoku Genitourinary Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Chugoku Shikoku Genitourinary Cancer Study Group
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
川崎医科大学附属病院（岡山県）、川崎医科大学附属川崎病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2017 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015001
