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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040358 |
Receipt No. | 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 | 2020/05/11 |
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 |
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Condition | ||
Condition | Castration-resistant prostate cancer (CRPC) with bone metastases | |
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
etom@uro.med.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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@uro.med.kyushu-u.ac.jp |
Sponsor | |
Institute | Department of Urology, Graduate School of Medical Sciences, Kyushu University |
Institute | |
Department |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045641 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |