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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)

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ClinicalTrials.gov Identifier: NCT03896984
Recruitment Status : Active, not recruiting
First Posted : April 1, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Metastatic Castration-resistant Prostate Cancer (mCRPC) Drug: Radium-223 (Xofigo, BAY88-8223) Drug: Abiraterone Drug: Enzalutamide

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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
Abi 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.

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
Abi 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.




Primary Outcome Measures :
  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 2018-09-30 ]
  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 2018-09-30 ]

Secondary Outcome Measures :
  1. Descriptive analysis of patient demography at baseline [ Time Frame: Retrospective analysis from 2013-01-01 to 2018-09-30 ]

    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 2018-09-30 ]

    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 lab values at baseline [ Time Frame: Retrospective analysis from 2013-01-01 to 2018-09-30 ]

    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 2018-09-30 ]
    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 2018-09-30 ]
  6. Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L [ Time Frame: Retrospective analysis from 2013-01-01 to 2018-09-30 ]
  7. Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L [ Time Frame: Retrospective analysis from 2013-01-01 to 2018-09-30 ]
  8. Period of time from initiation of 2L to first SSE [ Time Frame: Retrospective analysis from 2013-01-01 to 2018-09-30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The primary study population consists of patients with documented mCRPC who either received Ra-223 or sequential NAH therapy after 1L NAH therapy respectively.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896984


Locations
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United States, New Jersey
US Flatiron prostate cancer database
Whippany, New Jersey, United States, 07981
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03896984     History of Changes
Other Study ID Numbers: 20526
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Radium Ra 223 dichloride
Hormones
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents