UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040358 |
|---|---|
| Receipt number | R000045641 |
| Scientific Title | Prospective multi-institutional study for Ra-223 in CRPC patients with bone metastasis |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2023/05/15 08:48:55 |
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Basic information
Public title
Prospective multi-institutional study for Ra-223 in CRPC patients with bone metastasis
Acronym
KYUCOG-1901
Scientific Title
Prospective multi-institutional study for Ra-223 in CRPC patients with bone metastasis
Scientific Title:Acronym
KYUCOG-1901
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer (CRPC) with bone metastases
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Development of monitoring method for Ra-223 treatment in CRPC patients with bone metastasis and to evaluate safety.
Basic objectives2
Others
Basic objectives -Others
To carry out genome-wide SNP analysis of
genome DNA extracted from blood using Japonica array.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in amount of circulating tumor DNA (ctDNA) and in type and frequency of each gene abnormality by radium-223 treatment.
Key secondary outcomes
Relationship between efficacy and prognosis of radium-223 treatment and amount of ctDNA, type and frequency and that changes of each gene abnormality.
Identification of single nucleotide polymorphisms (SNPs) in genomic DNA that correlate with efficacy and prognosis of radium-223 treatment.
Effectiveness and prognosis of radium-223
treatment.
Radium-223 adverse events, bone effects.
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
1.Histologically or cytologically confirmed prostate cancer.
2.The patients diagnosed as CRPC.
3.Patients undergoing continuous androgen removal by GnRH agonist and antagonist or bilateral orchiectomy.
4.Multiple bone metastases (>=2 hot spots) detected by bone scintigraphy within previous 12 weeks.
5.Age 20 years or older at the time of
consent acquisition.
6.Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-2.
7.Expected survival is more than 6 months.
8.Preserved hematologic function within 4 weeks as follows;
Absolute neutrophil count (ANC)>=
1500/mm3
Platelet count >=100,000/mm3
Hemoglobin >=10.0 g/dL
9.Patients who fully understand this research plan and can give their consent.
Key exclusion criteria
1.Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases within previous 24 weeks.
2.Prior treatment with radium-223
3.Had history of gastrointestinal bleeding within 12 weeks.
4.Any active other malignancy.
5.History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations.
6.Patients with or confirmed a history of metastatic brain tumor.
7.Malignant lymphadenopathy exceeding 1.5 cm in short-axis diameter.
8. Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging).
9.Any other serious illness or medical condition.
10.Substance abuse,medical,psychological,
or social conditions that might interfere with the subject's participation in the study or evalution of the study results
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Eto |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Urology
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5601
eto.masatoshi.717@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Shiota |
Organization
Kyushu University Hospital
Division name
Department of Urology
Zip code
812-8582
Address
3-1-1 Maidashi Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5603
Homepage URL
shiota.masaki.101@m.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Urology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Network Fukuoka Certified Review Board
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
092-643-7171
mail@crnfukuoka.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
| 2020 | Year | 05 | Month | 11 | 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
100
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
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Extraction of DNA from blood specimen.
2. SNP analysis using Japonica array.
3.Statistical analysis of correlation with clinical information.
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045641
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
