UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007858 |
|---|---|
| Receipt number | R000009260 |
| Scientific Title | Study on evaluation of treatment and prognosis using Bon Scan Index (BSI) in the bone scintigraphy at the prostate cancer bone metastases evaluation |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2021/11/04 16:26:13 |
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Basic information
Public title
Study on evaluation of treatment and prognosis using Bon Scan Index (BSI) in the bone scintigraphy at the prostate cancer bone metastases evaluation
Acronym
The evaluation of bone metastases using BSI in the bone scintigraphy
Scientific Title
Study on evaluation of treatment and prognosis using Bon Scan Index (BSI) in the bone scintigraphy at the prostate cancer bone metastases evaluation
Scientific Title:Acronym
The evaluation of bone metastases using BSI in the bone scintigraphy
Region
| Japan |
Condition
Condition
Prostate cancer with bone metastasis
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Quantification of the result in the bone scintigraphy using the BSI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between rate of change PSA and the bone turnover markers and rate of change of the BSI by the treatment
Key secondary outcomes
The correlation between progression-free survival and overall survival and rate of change of the BSI 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
Prostate cancer with bone metastasis before hormonal therapy or Recurred prostate cancer with bone metastasis before docetaxel treatment
Key exclusion criteria
prostate cancer without bone metastasis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Mizokami |
Organization
Kanazawa University Hospital
Division name
Department of Urology
Zip code
920-8641
Address
13-1 takaramachi, Kanazawa
TEL
076-265-2393
mizokami@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Mizokami |
Organization
Kanazawa University Hospital
Division name
Department of Urology
Zip code
920-8641
Address
13-1 takaramachi, Kanazawa
TEL
076-265-2393
Homepage URL
mizokami@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Fuji Film RI Pharma
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
Kanazawa Univerisity
Address
13-1 Takaramachi, Kanazawa, Ishikawa
Tel
076-265-2000
mizokami@staff.kanazawa-u.ac.jp
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
| 2012 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/29633398
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
247
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Now we are submitting the result and waiting for the accept.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
There was not adverse effects because of observational study.
Outcome measures
The primary end-points are post-treatment changes in BSI compared with baseline and event-free and PSA progression- free survival. Secondary end-points include changes in BSI determined by an ANN, other parameters of PSA, bone meta- bolic markers and overall survival from baseline until the end of post-treatment follow up for 3 years.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Investigate the correlation between BSI using bonenavi in bone scintigraphy and PSA and bone turnover marker.
Management information
Registered date
| 2012 | Year | 04 | Month | 28 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009260
