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UMIN-CTR Clinical Trial |
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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 |
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 |
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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 | 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 |
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Interventions/Control_1 | Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with flutamide. | |
Interventions/Control_2 | ||
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Interventions/Control_5 | ||
Interventions/Control_6 | ||
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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) 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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Chiba University |
Institute | |
Department |
Funding Source | |
Organization | Bayer Yakuhin, Ltd. |
Organization | |
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Category of Funding Organization | Profit organization |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Management information | |||||||
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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=R000035312 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
Registered date | File name |