UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004718 |
|---|---|
| Receipt number | R000005615 |
| Scientific Title | Effect of Strontium-89 on painful bone metastases in zoledronic acid received patients with prostate cancer |
| Date of disclosure of the study information | 2010/12/20 |
| Last modified on | 2014/06/18 19:19:03 |
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Basic information
Public title
Effect of Strontium-89 on painful bone metastases in zoledronic acid received patients with prostate cancer
Acronym
Effect of Strontium-89 on painful bone metastases in zoledronic acid received patients with prostate cancer
Scientific Title
Effect of Strontium-89 on painful bone metastases in zoledronic acid received patients with prostate cancer
Scientific Title:Acronym
Effect of Strontium-89 on painful bone metastases in zoledronic acid received patients with prostate cancer
Region
| Japan |
Condition
Condition
Prostate Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of the combination of Strontium-89 for painful bone metastases in patients with hormone refractory prostate cancer in subjects with uncontrolled bone pain by zoledronic acid
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate (the ratio of responder to bone pain)
Key secondary outcomes
Safety and mechanism(changes in the level of tumor marker and bone turnover marker)
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
1. Diagnosis of prostate cancer was confirmed
2. Stage D (with bone metastasis) prostate cancer
3. Case with tumor marker positive and history of hormonal therapy and that have been receiving zoledronic acid for at least a month.
4. ECOG performance status 0-2
5 Case with multiple bone metastases demonstrated on standard bone scintigraphy, with bone pain localized in the areas of higher up-take.
6. Case with using analgesic such as NSAIDs or opioid for painful bone metastases
7. WBC>3,000/mm3, neutrophil>1,500/mm3, platelet>75,000/mm3, Hb>9.0g/dL, and at a case after chemotherapy or external radiotherapy, the nadir of each parameter is confirmed.
8.Case that DIC is excluded and with no rapid decrease in platelet count
9. Case that survival more than 1 month is anticipated
10.Case signed informed consent of the patients for the registration
Key exclusion criteria
1. Patients with severe renal failure
2. Patients with ongoing chemotherapy
3. Patients with ongoing external radiotherapy
4. Patients with unmanageable urinary incontinence
5. Patients with severe complication
6. Patients with history of drug allergy that are considered inappropriate to conduct this trial
7. Other patients deemed not appropriate for study entry by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Oya |
Organization
Keio University Shool of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohiko Nagata |
Organization
Keio University Shool of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-3353-1211
Homepage URL
hironagata-jua@umin.ac.jp
Sponsor or person
Institute
Keio University Shool of Medicine
Department of Urology
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the efficacy and the safety of the combination of Strontium-89 for painful bone metastases in patients with hormone refractory prostate cancer in subjects with uncontrolled bone pain by zoledronic acid
Management information
Registered date
| 2010 | Year | 12 | Month | 13 | Day |
Last modified on
| 2014 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005615
