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)

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Intervention / Treatment: Drug: Radium-223 (Xofigo, BAY88-8223); Drug: Abiraterone; Drug: Enzalutamide

• Study Type: Observational
• Enrollment (Actual): 346

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • US Flatiron prostate cancer database

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Descriptive analysis of patient demography at baseline	Demographic characteristics includes: Gender (expecting 100% male); Age (in the year of index date); Ethnicity	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)	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)	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	Retrospective analysis from 2013-01-01 to 2018-12-30
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Sartor O, George D, Tombal B, Agarwal N, Higano CS, Sternberg CN, Miller K, Jiao X, Guo H, Sandstrom P, Bruno A, Verholen F, Saad F, Shore N. Real-world outcomes of second novel hormonal therapy or radium-223 following first novel hormonal therapy for mCRPC. Future Oncol. 2022 Jan;18(1):35-45. doi: 10.2217/fon-2021-0886. Epub 2021 Oct 12.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): June 8, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 20526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No