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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024201
Receipt No. 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

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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
Email 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
Email chikens@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027598

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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