UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004517 |
|---|---|
| Receipt number | 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 13:30:40 |
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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
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
miyoyasu@med.yokohama-cu.ac.jp
Public contact
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
miyoyasu@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005373
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
