Unique ID issued by UMIN | UMIN000040358 |
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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 |
Prospective multi-institutional study for Ra-223 in CRPC patients with bone metastasis
KYUCOG-1901
Prospective multi-institutional study for Ra-223 in CRPC patients with bone metastasis
KYUCOG-1901
Japan |
Castration-resistant prostate cancer (CRPC) with bone metastases
Urology |
Malignancy
YES
Development of monitoring method for Ra-223 treatment in CRPC patients with bone metastasis and to evaluate safety.
Others
To carry out genome-wide SNP analysis of
genome DNA extracted from blood using Japonica array.
Exploratory
Not applicable
Changes in amount of circulating tumor DNA (ctDNA) and in type and frequency of each gene abnormality by radium-223 treatment.
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.
Observational
20 | years-old | <= |
Not applicable |
Male
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.
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
100
1st name | Masatoshi |
Middle name | |
Last name | Eto |
Graduate School of Medical Sciences, Kyushu University
Department of Urology
812-8582
3-1-1 Maidashi Higashi-ku, Fukuoka 812-8582, Japan
092-642-5601
eto.masatoshi.717@m.kyushu-u.ac.jp
1st name | Masaki |
Middle name | |
Last name | Shiota |
Kyushu University Hospital
Department of Urology
812-8582
3-1-1 Maidashi Higashi-ku, Fukuoka 812-8582, Japan
092-642-5603
shiota.masaki.101@m.kyushu-u.ac.jp
Department of Urology, Graduate School of Medical Sciences, Kyushu University
Bayer Yakuhin, Ltd
Profit organization
Clinical Research Network Fukuoka Certified Review Board
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
092-643-7171
mail@crnfukuoka.jp
NO
2020 | Year | 05 | Month | 11 | Day |
Unpublished
100
No longer recruiting
2020 | Year | 01 | Month | 31 | Day |
2020 | Year | 04 | Month | 27 | Day |
2020 | Year | 06 | Month | 01 | Day |
2025 | Year | 10 | Month | 31 | Day |
1.Extraction of DNA from blood specimen.
2. SNP analysis using Japonica array.
3.Statistical analysis of correlation with clinical information.
2020 | Year | 05 | Month | 11 | Day |
2023 | Year | 05 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045641
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