Prostate Cancer, Castration Resistant
Conditions
Keywords
Prostate cancer, Bone metastases, Xofigo
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.
Interventions
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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)) |
| 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 |
| hospital length of stay | Up to 30 months | — |
| Non-laboratory based clinically relevant safety outcomes | Up to 30 months | documented in medical records |
| 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 |
Countries
United States
Outcome results
None listed