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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030946
Receipt No. R000035312
Scientific Title Efficacy and Safety of Ra-223 as 1st line therapy in combination with alternative anti-androgen therapy for bone metastatic CRPC Patients
Date of disclosure of the study information 2018/01/23
Last modified on 2018/01/23

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Basic information
Public title Efficacy and Safety of Ra-223 as 1st line therapy in combination with alternative anti-androgen therapy for bone metastatic CRPC Patients
Acronym 1st Ra-223 Therapy Trial
Scientific Title Efficacy and Safety of Ra-223 as 1st line therapy in combination with alternative anti-androgen therapy for bone metastatic CRPC Patients
Scientific Title:Acronym 1st Ra-223 Therapy Trial
Region
Japan

Condition
Condition Castration-resistant prostate cancer (CRPC) with bone metastases
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of Radium-223 (Ra-223) in combination with alternative anti-androgen therapy as 1st line therapy in Japanese patients with bone metastatic CRPC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) % change in ALP at 12week
Key secondary outcomes 1) % change in ALP at 24week
2) % change in PSA at 12 and 24weeks
3) % changes in Bone markers (BAP, TRACP-5B) at 12 and 24 weeks
4) Bone Scan Index (BSI)
5) QOL( EQ-5D-5L, Japanese Brief Pain Inventory (BPI-J) )
6) Completion rate of Ra-223 administration
7) Overall Survival (OS)
8) Symptomatic Skeletal Events-Free Survival (SSE-FS)
9) Time to visceral metastases
10) Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with flutamide.
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) Patients diagnosed asymptomatic or symptomatic CRPC with bone predominant metastatic and with no visceral metastasis (lymph node (<= 3cm) metastasis is allowed)
3) Confirmed PSA progression with bicalutamide as 1st anti-androgen agent under Combined Androgen Blockade (CAB). Being received or planned to receive flutamide as alternative anti-androgen therapy.
4) Multiple skeletal metastases (>= 2 hot spots) on bone scintigraphy within previous 12 weeks
5) No experience of treatment with neither Abiraterone, Enzalutamide, Docetaxel, nor Cabazitaxel
6) Life expectancy >= 6 months
7) ECOG Performance status : 0 or 1
8) Adequate hematologic, renal, and liver function
・Absolute neutrophil count >= 1.5 x 10^9/L
・Platelet count >= 100 x10^9/L
・Hemoglobin >= 10.0 g/dL
・Total bilirubin, AST, ALT, and creatine <= 1.5 x institutional upper limit of normal (ULN)
9) Fully informed about the study; willing and able to comply with the protocol; must be signed the informed consent form

Key exclusion criteria 1) Treatment history of cytotoxic chemotherapy (including Estramustine
2) Prior hemibody external radiation therapy
3) Systemic radiation therapy with radioisotopes (storontium-89, samarium-153, rhenium-186, or rhenium-188) within previous 24 weeks
4) Prior treatment of Ra-223
5) Blood transfusion or erythropoietin-stimulating agents within the previous 4 weeks
6) Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
7) History or presence of visceral metastases or brain metastases
8) Malignant lymphadenopathy exceeding 3 cm in short-axis diameter
9) Imminent or established spinal cord compression. Patients with history of spinal cord compression must have completely recovered
10) Presence of liver disorders
11) Any other serious illness or medical condition such as, but not limited to; any uncontrolled infection; cardiac failure NYHA III or IV; Crohn's disease or Ulcerative colitis; Bone marrow dysplasia
12)Unmanageable faecal incontinence
13) Patients who are inappropriate for the participation into this study due to any other reasons judged by each institutional physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Sakamoto, M.D., PhD
Organization Graduate School of Medicine and School of Medicine, Chiba University
Division name Department of Urology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL 043-226-2134
Email rbatbat1@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Sakamoto, M.D., PhD
Organization Graduate School of Medicine and School of Medicine, Chiba University
Division name Department of Urology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL 043-226-2134
Homepage URL
Email rbatbat1@gmail.com

Sponsor
Institute Chiba 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
Address
Tel
Email

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
2018 Year 01 Month 23 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 23 Day
Last modified on
2018 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035312

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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