Prospective study of evaluating the efficacy and safety of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Phase 2
- Conditions
- castration-resistant prostate cancer with bone metastases
- Registration Number
- JPRN-UMIN000023897
- Lead Sponsor
- ational Hospital Organization Saitama Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1) organ metastases excluding bone metastases 2) active concomitant malignancy 3) inflammatory bowel disease (Crohn's disease or ulcerative colitis) 4) use of chemotherapy with myelosuppresion reaction at the same time 5) difficult to participate with the trial, having mentel disorder or psychiatric symptoms 6) immuno-suppression treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change rate of PSA at six month after completion of Radium-223 dichloride therapy
- Secondary Outcome Measures
Name Time Method Rates of Adverse events, improvement rate of pain from bone metastases, bone metastases progressive free survival, distant metastases free survival excluding bone metastases, pattern of progression, overall survival