UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023897 |
|---|---|
| Receipt number | R000027376 |
| Scientific Title | Prospective study of evaluating the efficacy and safety of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2023/03/09 01:49:47 |
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Basic information
Public title
Prospective study of evaluating the efficacy and safety of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Acronym
Prospective study of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Scientific Title
Prospective study of evaluating the efficacy and safety of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Scientific Title:Acronym
Prospective study of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Region
| Japan |
Condition
Condition
castration-resistant prostate cancer with bone metastases
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effectiveness of Radium-223 dichloride for castration-resistant prostate cancer with bone metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
change rate of PSA at six month after completion of Radium-223 dichloride therapy
Key secondary outcomes
Rates of Adverse events, improvement rate of pain from bone metastases, bone metastases progressive free survival, distant metastases free survival excluding bone metastases, pattern of progression, overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Radium-223 dichloride (55 kBq/kg) on day 1 every 4 weeks
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
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Confirmation of castration-resistant prostate cancer and bone metastases
2) Age from 20 to 80 years old
3) Preserved hematologic function within 28 days as follows;
i) neutrophile count >=1,500/mm3
ii) hemoglobin >= 10.0 g/dL
iii) platelet count >=100,000/mm3
4) Written informed consent is taken.
Key exclusion criteria
1) organ metastases excluding bone metastases
2) active concomitant malignancy
3) inflammatory bowel disease (Crohn's disease or ulcerative colitis)
4) use of chemotherapy with myelosuppresion reaction at the same time
5) difficult to participate with the trial, having mentel disorder or psychiatric symptoms
6) immuno-suppression treatment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Momma |
Organization
National Hospital Organization Saitama Hospital
Division name
Urology
Zip code
351-0102
Address
2-1, Suwa, Wako-shi, Saitama, 351-0102, JAPAN
TEL
048-462-1101
monma-jua@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Momma |
Organization
National Hospital Organization Saitama Hospital
Division name
Urology
Zip code
351-0102
Address
2-1, Suwa, Wako-shi, Saitama, 351-0102, JAPAN
TEL
048-462-1101
Homepage URL
monma-jua@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Saitama Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Saitama Hospital
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
Ethics Committee, National Hospital Organization Saitama Hospital
Address
2-1, Suwa, Wako-shi, Saitama, 351-0102, JAPAN
Tel
048-462-1101
hiizuka@wakho.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027376
