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Completed

NCT Number: NCT03896984

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).

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.

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Sex eligibility

Male

Study type

Observational

Primary location

US Flatiron prostate cancer database

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 (Xofigo, Bay88-8223)

Drug

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.

Abiraterone

Drug

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.

Enzalutamide

Drug

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.

Primary outcomes

  1. Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy

    Time frame: Retrospective analysis from 2013-01-01 to 2018-12-30

  2. Overall survival (OS) from initiation of 2L therapy of sequential NAH in patients with mCRPC after 1L NAH therapy

    Time frame: Retrospective analysis from 2013-01-01 to 2018-12-30

Secondary outcomes

  1. Descriptive analysis of patient demography at baseline

    Time frame: 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

  2. Descriptive analysis of clinical characteristics of patients at baseline

    Time frame: 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)

  3. Descriptive analysis of laboratory values at baseline

    Time frame: 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)

  4. Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L

    Time frame: Retrospective analysis from 2013-01-01 to 2018-12-30

    SSE:Symptomatic skeletal event

  5. Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L

    Time frame: Retrospective analysis from 2013-01-01 to 2018-12-30

  6. Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L

    Time frame: Retrospective analysis from 2013-01-01 to 2018-12-30

  7. Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L

    Time frame: Retrospective analysis from 2013-01-01 to 2018-12-30

  8. Period of time from initiation of 2L to first SSE

    Time frame: Retrospective analysis from 2013-01-01 to 2018-12-30

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: PHENIX

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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