Trial Condition(s):
Metastatic castration-resistant prostate cancer (mCRPC)
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). (PHENIX)
Bayer Identifier:
20526
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Patients with documented mCRPC receiving 1L NAHs. - Initiation of Ra-223 after 1L NAH therapy, or - Initiation of sequential NAH therapy after 1L NAH therapy
Exclusion Criteria
- Patients involved in clinical trials - Patients who received combined therapies in 1L or 2L
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations US Flatiron prostate cancer database Whippany, United States, 07981 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
DescriPtive analysis of real-world clinical outcomes of second line (2L) novel anti-HormonE therapy (NAH) or RadIum-223 (Xofigo) in patients with metastatic castration resistance prostate cancer (mCRPC) after first line (1L) NAH therapy
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapyTimeframe: 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 therapyTimeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary Outcome
- Descriptive analysis of patient demography at baselineDemographic characteristics includes: - Gender (expecting 100% male) - Age (in the year of index date) - EthnicityTimeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
- Descriptive analysis of clinical characteristics of patients at baselineClinical 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)Timeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
- Descriptive analysis of laboratory values at baselineThe laboratory tests of interest includes: - Prostate Specific Antigen(PSA) - Alkaline Phosphatase(ALP) - Hemoglobin (Hgb) - Lactate dehydrogenase (LDH)Timeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
- Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2LSSE:Symptomatic skeletal eventTimeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
- Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2LTimeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
- Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2LTimeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
- Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2LTimeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
- Period of time from initiation of 2L to first SSETimeframe: Retrospective analysis from 2013-01-01 to 2018-12-30
Additional Information
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