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Project plan changed, study conduct was no longer needed.
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There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium-223 concomitant with Abiraterone or Enzalutamide | Approximately 150 medical charts from mCRPC patients within the network will be collected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radium Ra 223 dichloride (Xofigo, BAY88-8223) | Drug | Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rates | Survival will be defined as time from initiation of first line therapy until death. Survival will be measured as the proportion of study subjects that are alive at the data cut-off or median time for survival of at least 50% of study subjects | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression | Disease progression will be defined as either of the below: PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progression | Up to 1 year |
| Skeletal related events (SRE) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be identified by their treating physicians (oncologists and urologists), who will be recruited for participation in the research from the Cardinal Health Oncology Research Network (CHORN).
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
| D000069501 | Abiraterone Acetate |
| C540278 | enzalutamide |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Zytiga | Drug | Abiraterone 1000 mg per day orally |
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| Xtandi | Drug | Enzalutamide 160 mg per day orally |
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SRE will be defined as: a pathologic fracture, spinal cord compression, necessity for radiation to bone for pain or impending fracture and/or surgery to bone |
| Up to 1 year |
| Symptomatic Skeletal Events (SSE) | SSE defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention | Up to 1 year |
| Time to death | Up to 1 year |
| Sequence of treatment regimens | Up to 1 year |
| Dose schedule | Up to 1 year |
| Duration of therapy | Up to 1 year |
| Time to first visceral metastasis | Up to 1 year |
| Proportion of patients developing visceral metastasis | Up to 1 year |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |