Castration-resistant prostate cancer (CRPC) with bone metastases
Conditions
Interventions
Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with flutamide.
Sponsors
Chiba University
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) % change in ALP at 12week | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShinichi Sakamoto, M.D., PhD
Graduate School of Medicine and School of Medicine, Chiba University Department of Urology
Outcome results
None listed