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).

Completed

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

• Registration Number: NCT03896984
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Primary Completion: 2020-06-08
• Study Completion: 2020-12-14
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 346

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort_2LX	Radium-223 (Xofigo, BAY88-8223)	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
Cohort_2LX	Abiraterone	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
Cohort_2LH	Abiraterone	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
Cohort_2LH	Enzalutamide	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
Cohort_2LX	Enzalutamide	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Descriptive analysis of patient demography at baseline	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
Descriptive analysis of clinical characteristics of patients at baseline	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)
Descriptive analysis of laboratory values at baseline	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)
Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L	Retrospective analysis from 2013-01-01 to 2018-12-30	SSE:Symptomatic skeletal event
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

Trial Locations

Locations (1)

US Flatiron prostate cancer database; 🇺🇸 Whippany, New Jersey, United States