check_circleStudy Completed

Metastatic castration-resistant prostate cancer (mCRPC)

Bayer Identifier:

20526

ClinicalTrials.gov Identifier:

NCT03896984

EudraCT Number:

Not Available

EU CT Number:

Not Available
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).

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.

Key Participants Requirements

Sex

Male

Age

NaN - N/A
  • - 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
346
Trial Dates
March 2019 - December 2020
Phase
N/A
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
US Flatiron prostate cancer databaseWhippany, 07981, United States

Primary Outcome

  • Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30

Secondary Outcome

  • Descriptive analysis of patient demography at baseline
    Demographic characteristics includes: - Gender (expecting 100% male) - Age (in the year of index date) - Ethnicity
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30
  • Descriptive analysis of clinical characteristics of patients at baseline
    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)
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30
  • Descriptive analysis of laboratory values at baseline
    The laboratory tests of interest includes: - Prostate Specific Antigen(PSA) - Alkaline Phosphatase(ALP) - Hemoglobin (Hgb) - Lactate dehydrogenase (LDH)
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30
  • Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L
    SSE:Symptomatic skeletal event
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30
  • Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30
  • Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30
  • Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30
  • Period of time from initiation of 2L to first SSE
    date_rangeTime Frame:
    Retrospective analysis from 2013-01-01 to 2018-12-30

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
N/A

Additional Information

Click here to find results for studies related to Bayer products.