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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035857
Receipt No. R000040835
Official scientific title of the study Early treatment effect and prognosis measurement of bone metastasis in prostate cancer patients by using whole-body diffusion-weighted imaging.
Date of disclosure of the study information 2019/02/12
Last modified on 2019/02/12

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Basic information
Official scientific title of the study Early treatment effect and prognosis measurement of bone metastasis in prostate cancer patients by using whole-body diffusion-weighted imaging.
Title of the study (Brief title) Bone metastasis evaluation in prostate cancer patients by using whole-body diffusion-weighted imaging.
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the early treatment effect and prognosis of bone metastasis in prostate cancer patients by using whole-body diffusion-weighted imaging.
We further evaluate the relationships among BD score, CTC, and cell free DNA in this study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of BD score 12 weeks after treatment
Key secondary outcomes Prediction of recurrence at the time of treatment-effect judgment
Relationship among BD score, CTC, and cell free DNA

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 Prostate cancer patients before or under hormonal therapy or chemotherapy who agreed written informed consent for participating in this study.
Key exclusion criteria 1) Under 20 years old
2) The person who has internal implantation material to operate electrically or magnetically such as heart pacemaker
3) History of claustrophobia
4) The person who are regarded as inadequate for this study by a responsibility researcher
Target sample size 60

Research contact person
Name of lead principal investigator Jinzaki Masahiro
Organization Keio University, School of Medicine
Division name Department of Diagnostic Radiology
Address 35, Shinanomachi, Shinjuku-Ku, Tokyo
TEL 03-3353-1211
Email jinzaki@rad.med.keio.ac.jp

Public contact
Name of contact person Shigeo Okuda
Organization Keio University, School of Medicine
Division name Department of Diagnostic Radiology
Address 35, Shinanomachi, Shinjuku-Ku, Tokyo
TEL 03-3353-1211
Homepage URL http://rad.med.keio.ac.jp/
Email okuda@rad.med.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University, School of Mrdicine
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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 12 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 01 Month 29 Day
Anticipated trial start date
2019 Year 02 Month 12 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 Prospective observational study
To evaluate improvement of BD score 12 weeks after treatment and prediction of recurrence at the time of treatment-effect judgment.

Management information
Registered date
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040835

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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