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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004517
Receipt No. R000005373
Scientific Title Safety and efficacy of strontium-89 for prostate cancer with painful bone metastases in Japanese patients
Date of disclosure of the study information 2010/11/08
Last modified on 2016/02/05

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Basic information
Public title Safety and efficacy of strontium-89 for prostate cancer with painful bone metastases in Japanese patients
Acronym Feasibility of strontium-89 for prostate cancer with painful bone metastases in Japanese patients
Scientific Title Safety and efficacy of strontium-89 for prostate cancer with painful bone metastases in Japanese patients
Scientific Title:Acronym Feasibility of strontium-89 for prostate cancer with painful bone metastases in Japanese patients
Region
Japan

Condition
Condition castration-resistant prostate cancer patients with painful bone metastases
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and effectivity
Key secondary outcomes

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
100 years-old >
Gender Male
Key inclusion criteria (1) Prostatic cancer with positive bone scintigraphy findings and painful bone metastasis
(2) No prior treatment with Sr-89
(3) Expected life span of more than 3 months
(4) Adequate hematologic functions
*In patients receiving chemotherapy, investigators must confirm a tendency to improvement in the laboratory value from the lowest level after treatment.
(5) Submission of informed consent for participation in this study after a full explanation of the study.
Key exclusion criteria (1) Severe myelosuppression
*Severe myelosuppression should be measured by hematologic functions (platelets < 50,000/mm3, WBC < 2,000/mm3, neutrophils < 1,000/mm3, Hb < 8.0/dL).
(2) Diagnosis of disseminated intravascular coagulation syndrome (DIC)
(3) Severe renal dysfunction (e.g. renal failure of NCI Common Toxicity Criteria Grade 3/4)
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasuhide Miyoshi
Organization Yokohama City Medical Center
Division name Derpartment of Urology
Zip code
Address 4-57 Urafune-cho Minami-ku Yokohama Japan
TEL +81-45-261-5656
Email miyoyasu@med.yokohama-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuhide Miyoshi
Organization Yokohama City Medical Center
Division name Derpartment of Urology
Zip code
Address 4-57 Urafune-cho Minami-ku Yokohama
TEL 045-261-5656
Homepage URL
Email miyoyasu@med.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City Medical Center
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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 横浜市立大学付属市民総合医療センター (神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 08 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 Open public recruiting
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
2013 Year 02 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information prospective study

Management information
Registered date
2010 Year 11 Month 08 Day
Last modified on
2016 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005373

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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