PHENIX: Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).
Study Details
Study Description
Brief Summary
In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy (NAH) or Radium-223 (Xofigo) after a prior NAH therapy (first line treatment). Additionally the researchers are also interested in the occurrence of bone fractures and other skeletal events. Basis for this study will be the US based Flatiron database which provides access to clinical data for cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort_2LX Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as first liine (1L) after diagnosis of mCRPC who then received Ra-223 monotherapy as second line (2L) treatment |
Drug: Radium-223 (Xofigo, BAY88-8223)
Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Drug: Abiraterone
Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.
Drug: Enzalutamide
Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.
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| Cohort_2LH Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as 1L after diagnosis of mCRPC who then received another NAH monotherapy (i.e., Abiraterone to Enzalutamide or Enzalutamide to Abiraterone) as 2L treatment. None of the patients had ever received Radium-223 dichloride |
Drug: Abiraterone
Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.
Drug: Enzalutamide
Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy [Retrospective analysis from 2013-01-01 to 2018-12-30]
- Overall survival (OS) from initiation of 2L therapy of sequential NAH in patients with mCRPC after 1L NAH therapy [Retrospective analysis from 2013-01-01 to 2018-12-30]
Secondary Outcome Measures
- Descriptive analysis of patient demography at baseline [Retrospective analysis from 2013-01-01 to 2018-12-30]
Demographic characteristics includes: Gender (expecting 100% male) Age (in the year of index date) Ethnicity
- Descriptive analysis of clinical characteristics of patients at baseline [Retrospective analysis from 2013-01-01 to 2018-12-30]
Clinical characteristics includes: Histology Gleason score Clinical stage (at initial diagnosis) T/N/M stage (at initial diagnosis) ECOG performance status Site of metastasis (visceral, lymph node, bone)
- Descriptive analysis of laboratory values at baseline [Retrospective analysis from 2013-01-01 to 2018-12-30]
The laboratory tests of interest includes: Prostate Specific Antigen(PSA) Alkaline Phosphatase(ALP) Hemoglobin (Hgb) Lactate dehydrogenase (LDH)
- Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L [Retrospective analysis from 2013-01-01 to 2018-12-30]
SSE:Symptomatic skeletal event
- Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L [Retrospective analysis from 2013-01-01 to 2018-12-30]
- Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L [Retrospective analysis from 2013-01-01 to 2018-12-30]
- Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L [Retrospective analysis from 2013-01-01 to 2018-12-30]
- Period of time from initiation of 2L to first SSE [Retrospective analysis from 2013-01-01 to 2018-12-30]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with documented mCRPC receiving 1L NAHs.
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Initiation of Ra-223 after 1L NAH therapy, or
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Initiation of sequential NAH therapy after 1L NAH therapy
Exclusion criteria:
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Patients involved in clinical trials
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Patients who received combined therapies in 1L or 2L
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | US Flatiron prostate cancer database | 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.- 20526