Japan nation-wide registry for Metastatic castration-resistant prostate cancer with BOne metastasis(JMBO)
- Conditions
- Castration-resistant prostate cancer with bone metastasis
- Registration Number
- JPRN-UMIN000029509
- Lead Sponsor
- The Japanese Urological Association
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 300
Not provided
1 Prior chemotherapy after dignosis of CRPC(except for UFT or EMT) 2 Prior hemibody extemal radiotherapy 3 Prior treatment with Stontium-89 for bone metastasis within 24 weeks from enrollment 4 Prior treatment with radium-223 5 Has history of gastrointestenal bleeding prior study entry 6 Any active other malignancy 7 History of visceral metastasis or presence of visceral metastasis detected by screening imaging examinations 8 History of or known brain metastasis 9 Malignant lymphadenopathy exceeding 3cm in shortaxis diameter 10 Imminent or established spinal cord compression based on clinical findings and/or MRI(Magnetic Resonance Imaging) 11 Any other serious illness or medical condition 12 Substance abuse,medical,psychological,or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment pattern (drugs used and their sequence) from diagnosis of CRPC to the end of follow-up in CRPC patients with bone metastasis and without visceral metastasis
- Secondary Outcome Measures
Name Time Method 1) Overall survival 2) Time to initiation of chemotherapy 3) Time to visceral metastasis 4) Time to SSE (symptomatic skeletal event) 5) Laboratory findings (e.g. ALP, bone markers) in overall population 6) QOL (EORTC-QLQ-c30, QLQ-BM22) 7) Bone Scan Index 8) Safety in Ra-223 patients