The study of combination therapy with radium-223 and enzalutamide in Osaka City University
- Conditions
- Castration-resistant prostate cancer with bone metastases
- Registration Number
- JPRN-UMIN000029422
- Lead Sponsor
- Osaka City University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 10
Not provided
1) Prior chemotherapy or planned treatment with chemotherapy 2) Prior PSA primary resistance to enzalutamide within previous 3 months 3) Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases within previous 24 weeks 4) Prior treatment with radium-223 5) Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry 6) History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations 7) History of or known brain metastasis 8) Malignant lymphadenopathy exceeding 1.5 cm in short-axis diameter 9) Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging) 10) Any serious complication for using rad-223 11) Any other serious illness or medical, psychological or social condition may interfere with the subject's participation in the study or evaluation of the study results 12) Those who judged to be inappropriate by the principal investigator or co-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ALP change from baseline
- Secondary Outcome Measures
Name Time Method 1. Proportion of patients who complete 6 times injections 2. The evaluation of bone metastases by bone scintigraphy and 18F-NaF PET 3. Overall survival 4. SSE-FS: symptomatic skeletal event-free survival 5. Time to initiation of chemotherapy 6. Time to visceral metastasis 7. PSA change from baseline 8. PRO (FACT-P, BPI) 9. Safety