Analysis of the efficacy and safety of Radium223 in men with advanced prostate cancer
Phase 3
Recruiting
- Conditions
- CancerMetastatic castration resistant prostate cancer with bone metastases
- Registration Number
- ISRCTN12835467
- Lead Sponsor
- Ospedale Civile Spirito Santo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 25
Inclusion Criteria
1. Patients with progressive mCRPC and castrate levels of testosterone (<50 ng/dl)
2. Chemonaive or postchemotherapy
3. Symptomatic bone metastases, treated with Radium 223
Exclusion Criteria
1. Patient <18 year old
2. Patient asymptomatic
3. Patient with ECOG >3
4. Patients with exclusive visceral metastases
5. Patient with non castrated testosterone levels
6. Patient concomitant use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, mitoxantrone
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival (defined as the time between treatment initiation and either the date of death or the last follow-up for surviving patients is measured using the patient records at monthly follow ups.
- Secondary Outcome Measures
Name Time Method 1. Treatment-related toxicity is measured using the National Cancer Institute Common Terminology Criteria for Adverse Events 4.02 toxicity scale monthly follow ups<br>2. Biochemical bone markers (alkaline phosphatase and bone alkaline phosphatase) and laboratory exams variation is measured using routine laboratory exams at monthly follow ups<br>3. Progression free survival (PFS) (defined as the time from the first dose of Radium 223 to the first clinical (pain, general status) or new radiographic event) measured using patients notes at monthly follow ups<br>4. Performance status is measured using the Eastern Cooperative Oncology Group (ECOG) and the pain by the Brief Pain Inventory scale at monthly follow ups