NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180442

Registered date:28/03/2019

1st Ra-223 Therapy Trial

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedCastration-resistant prostate cancer (CRPC) with bone metastases
Date of first enrollment19/03/2018
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with flutamide and bone modifying agent.

Outcome(s)

Primary Outcome% change in ALP at 12week
Secondary Outcome1. % 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. Fracture 11. Safety

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderMale
Include criteria1. Patients who are over 20 years of age at consent acquisition 2. Histologically or cytologically confirmed prostate cancer 3. Patients diagnosed asymptomatic or symptomatic CRPC with bone predominant metastatic and with no visceral metastasis (lymph node (<= 3cm) metastasis is allowed) 4. 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. 5. Multiple skeletal metastases (>= 2 hot spots) on bone scintigraphy within previous 12 weeks 6. No experience of treatment with neither Abiraterone, Enzalutamide, Apalutamide (ARN-509), Docetaxel, Cabazitaxel, nor Darolutamide (ODM-201) 7. Life expectancy >= 6 months 8. ECOG Performance status : 0 or 1 9. Adequate hematologic, renal, and liver function Absolute neutrophil count >= 1.5 x 109/L Platelet count >= 100 x 109/L Hemoglobin >= 10.0 g/dL Total bilirubin, AST, ALT, and creatine <= 1.5 x institutional upper limit of normal (ULN) 10. Fully informed about the study; willing and able to comply with the protocol; must be signed the informed consent form
Exclude criteria1. 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

Related Information

Contact

Public contact
Name Shinichi Sakamoto
Address 1-8-1 Inohana Chuou-ku, Chiba, Chiba Chiba Japan 260-8670
Telephone +81-432262134
E-mail rbatbat1@chiba-u.jp
Affiliation Chiba University Hospital
Scientific contact
Name Shinichi Sakamoto
Address Chiba Chiba Japan 260-8670
Telephone +81-432262134
E-mail rbatbat1@chiba-u.jp
Affiliation Chiba University Hospital