Efficacy and Safety of Ra-223 as 1st line therapy in combination with alternative anti-androgen therapy for bone metastatic CRPC Patients
- Conditions
- Castration-resistant prostate cancer (CRPC) with bone metastases
- Registration Number
- JPRN-UMIN000030946
- Lead Sponsor
- Chiba University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) % change in ALP at 12week
- Secondary Outcome Measures
Name Time Method 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