UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024201 |
|---|---|
| Receipt number | R000027598 |
| Scientific Title | Evaluation of effects of Ra-223 chloride therapy for bone metastasis of prostate cancer by quantitative bone SPECT/CT |
| Date of disclosure of the study information | 2016/09/28 |
| Last modified on | 2021/07/10 10:10:16 |
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Basic information
Public title
Evaluation of effects of Ra-223 chloride therapy for bone metastasis of prostate cancer by quantitative bone SPECT/CT
Acronym
Evaluation of Ra-223 therapy for bone metastasis of prostate cancer by quantitative bone SPECT/CT
Scientific Title
Evaluation of effects of Ra-223 chloride therapy for bone metastasis of prostate cancer by quantitative bone SPECT/CT
Scientific Title:Acronym
Evaluation of Ra-223 therapy for bone metastasis of prostate cancer by quantitative bone SPECT/CT
Region
| Japan |
Condition
Condition
Bone metastasis of castration resistant prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Ra-223 chloride was a novel alpha-emitter for bone metastasis radionuclide therapy, proved the elongation of over-all survival and the delay of skeletal related events. There is no clear evidence of the difference between the effective and non-effective patients. Bone scintigraphy is expected useful for evaluation of the effect of Ra-223 because it is a bone-seeking agent similar to Ra-223. Bone scintigraphy has been evaluated mainly by visual inspection. Recently a bone scan index (BSI) which comes from whole-body images with the automated software is available. A new SPECT/CT which enables precise SUV measurement in our hospital may detect early response to Ra-223 therapy. We explore the possibility of stratification of Ra-223 therapy using the bone SUV observing the serial change by Ra-223 therapy.
Basic objectives2
Others
Basic objectives -Others
Development of evaluation method by bone SUV
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between bone SUV or bone scan index (BSI) and bone pain evaluation score (VAS score)
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
| Not applicable |
Gender
Male
Key inclusion criteria
･ A patient with bone metastasis of castration resistant prostate cancer
･ A patient without known massive metastatic lesion except bone metastasis
･ A patient who is done or planned a quantitative bone SPECT/CT within 30 days before the initial administration of Ra-233 therapy
･ A patient who consents to this study on the document form
Key exclusion criteria
･ A patient with worse bone marrow dysfunction more than WHO grade III
･ A patient with any massive metastatic lesion except bone, such as brain, lung or liver
･ A patient who received radiation therapy or surgical therapy within 30 days, or who plans either therapy
･ A patient who deny the prosecution of this study in the middle of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ichiei |
| Middle name | |
| Last name | Kuji |
Organization
Saitama Medical University International Medical Center
Division name
Department of Nuclear Medicine
Zip code
350-1298
Address
Yamane 1397-1, Hidaka, Saitama
TEL
042-984-4147
kuji@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ichiei |
| Middle name | |
| Last name | Kuji |
Organization
Saitama Medical University International Medical Center
Division name
Clinical test assistant center
Zip code
350-1298
Address
Yamane 1397-1, Hidaka, Saitama
TEL
042-984-4523
Homepage URL
chikens@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center Crinical trial IRB
Address
Yamane 1397-1, Hidaka, Saitama
Tel
042-984-4523
chikens@saitama-med.ac.jp
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
埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
29
Results
Compared with BSI (bone scan index) evaluated by the whole-body image, changes similar to MBV (metabolic bone volume) and TBU (total bone uptake) were shown, and BSI, MBV, and TBU seemed to reflect the total amount of bone metastasis lesions. SUVmax correlated with BAP (bone-specific alkaline phosphatase) and seemed to reflect bone metastasis osteoblastic activity.
Results date posted
| 2021 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ra-223 Treatment Candidates in Patients with Castration-Resistant Prostate Cancer
Participant flow
This research was recruited from applicants for Ra-223 treatment at Saitama Medical University International Medical Center.
Adverse events
No
Outcome measures
SUV, BSI, BAP, MVB, TBU
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Body weight, Bone pain (VAS score), Blood (blood counts, PSA, ALP, PSA, BAP, 1-CTP) Urine (NTX),Bone scintigraphy (E.O.D.,BSI,SUV)
Management information
Registered date
| 2016 | Year | 09 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027598
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