UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030946 |
|---|---|
| Receipt number | 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 09:41:04 |
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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
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
rbatbat1@gmail.com
Sponsor or person
Institute
Chiba 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035312
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