UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007858
Receipt No. 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 2021/05/05

* 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 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
Email 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
Email mizokami@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
Email 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 No longer recruiting
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 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009260

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.