UMIN-CTR Clinical Trial

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
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Interventions/Control_2
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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
Email	etom@uro.med.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
Email	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
Email	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
Results
Results date posted
Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
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	2024 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	2020 Year 05 Month 11 Day

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
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