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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011648
Receipt No. R000013619
Official scientific title of the study 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

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Basic information
Official scientific title of the study Evaluation of therapeutic effect on prostate cancer patients with bone metastases using Bone Scan Index (BSI)
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Norio Nonomura
Organization Osaka University Graduate School of Medicine
Division name Department of Organ Specific Regulation (Urology)
Address 2-2 yamada-oka, Suita, Osaka
TEL 81668793531
Email nono@uro.med.osaka-u.ac.jp

Public contact
Name of contact person Motohide Uemura
Organization Osaka University Graduate School of Medicine
Division name Department of Organ Specific Regulation (Urology)
Address 2-2 yamada-oka, Suita, Osaka
TEL 81668793531
Homepage URL
Email uemura@uro.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013619


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