Multi-academic Center Study of Xofigo Patients
Study Details
Study Description
Brief Summary
The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.
The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ra-223 therapy before chemotherapy Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy |
Drug: Xofigo
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
Drug: Taxotere
Docetaxel injection 75mg/m2 every 3 weeks
Drug: Jevtana
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
|
| Ra-223 after chemotherapy Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy |
Drug: Xofigo
Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
Drug: Taxotere
Docetaxel injection 75mg/m2 every 3 weeks
Drug: Jevtana
Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
|
Outcome Measures
Primary Outcome Measures
- Overall survival [Up to 30 months]
Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).
- Time to symtomatic skeletal event(SSE) [Up to 30 months]
Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
- Reasons for treatment discontinuation [Up to 30 months]
data for treatment discontinuation for each mCRPC therapy will be collected
Secondary Outcome Measures
- Laboratory-based outcomes collected by questionnaire [Up to 30 months]
Data will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxel
- Treatments received [Up to 30 months]
measured as Yes/No
- Number of hospitalizations [Up to 30 months]
along with the discharge diagnosis, as recorded in medical charts or discharge summaries
- PSA PFS [Up to 30 months]
defined as death or an increase above PSA nadir by ≥25% and ≥2 ng/mL (PCWG 2008 definition for Prostate specific antigen(PSA) Progression-free survival(PFS))
- Non-laboratory based clinically relevant safety outcomes [Up to 30 months]
documented in medical records
- hospital length of stay [Up to 30 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Received at least one dose of radium-223 after mCRPC diagnosis
-
Received at least one prescription or dose of chemotherapy for treatment of mCRPC
Exclusion Criteria:
- No documented visceral metastasis at initiation of radium-223
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bayer US | Whippany | New Jersey | United States | 07981 |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19863