UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011648 |
|---|---|
| Receipt number | R000013619 |
| Scientific Title | Evaluation of therapeutic effect on prostate cancer patients with bone metastases using Bone Scan Index (BSI) |
| Date of disclosure of the study information | 2013/09/04 |
| Last modified on | 2013/09/04 08:52:52 |
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Basic information
Public title
Evaluation of therapeutic effect on prostate cancer patients with bone metastases using Bone Scan Index (BSI)
Acronym
Evaluation of therapeutic effect of prostate cancer by BSI
Scientific Title
Evaluation of therapeutic effect on prostate cancer patients with bone metastases using Bone Scan Index (BSI)
Scientific Title:Acronym
Evaluation of therapeutic effect of prostate cancer by BSI
Region
| Japan |
Condition
Condition
Prostate cancer patients with bone metastasis
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and quantify the therapeutic effect by BSI in bone scintigraphy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The change rate of BSI before and after treatment
Key secondary outcomes
The correlation between change rate of BSI and SRE event rate
The correlation between change rate of BSI and PSA, bone turnover markers
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1.Male patients who were histologically diagnosed as prostate cancer
2.Patients who underwent 99mTc-MDP bone scintigraphy and have more than one bone metastasis
3.Patients who expects more than 6 months life
4. Patients older than 20 years
5.Patients who offered written informed consent
Key exclusion criteria
1. Patients with difficulty in bone scintigraphy data analsysis due to the structural deformity or extraosseous uptake in bone scintigraphy
2. Patients corresponding to contraindication of Tc 99m methylene diphosphonate
3.Patient who were inappropriate for this study judged by medical doctor
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Nonomura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Organ Specific Regulation (Urology)
Zip code
Address
2-2 yamada-oka, Suita, Osaka
TEL
81668793531
nono@uro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohide Uemura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Organ Specific Regulation (Urology)
Zip code
Address
2-2 yamada-oka, Suita, Osaka
TEL
81668793531
Homepage URL
uemura@uro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 04 | 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
| 2013 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the change rate of BSI before and 6 months after treatment prospectively.
And the correlation between BSI and PSA or bone turnover markers also investigate.
Management information
Registered date
| 2013 | Year | 09 | Month | 04 | Day |
Last modified on
| 2013 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013619
