check_circleStudy Completed

Metastatic Castration Resistant Prostate Cancer

Bayer Identifier:
22697
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
An Observational Study examining Radium-223 Utilization Patterns in Men with Prostate Cancer utilizing the Surveillance, Epidemiology, and End-Results linked Medicare Database

Trial purpose

An Observational Study examining Radium-223 Utilization Patterns in Men with Prostate Cancer utilizing the Surveillance, Epidemiology, and End-Results linked Medicare Database

Key Participants Requirements

Sex

Male

Age

67 - N/A
  • - Ra-223 Initiation: Individuals initiated with Ra-223 between JAN 2016 and JUN 2020
    - Older men (age > 66 years at Ra-223 initiation)
    - Older men who have maintained uninterrupted Medicare coverage (Parts A, B, and D) for a minimum of 12 months leading up to their initiation of Ra-223. Furthermore, continuous Medicare coverage was required for 6 months or until death if a patient died within six months of initiation of Ra-223.
    - Metastasis diagnosis: Individuals diagnosed with metastases identified through the registry or having at least 2 diagnosis codes for metastases prior to Ra-223 use
  • - Health Maintenance Organization (HMO) enrollment: Men with any HMO coverage during the study period.
    - Presence of multiple cancers: Men with other cancers during the study period

Trial summary

Enrollment Goal
1062
Trial Dates
February 2024 - August 2024
Phase
N/A
Could I Receive a placebo
N/A
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, USA

Primary Outcome

  • Receipt and non-receipt of 5+ cycles Ra-223 treatment
    date_rangeTime Frame:
    Follow-up until death, end of continuous enrollment or 31 DEC 2020

Secondary Outcome

  • Characteristics of Ra-223 treated population
    date_rangeTime Frame:
    Follow-up until death, end of continuous enrollment or 31 DEC 2020
  • Ra-223 monotherapy over a combination/layered therapy
    date_rangeTime Frame:
    Follow-up until death, end of continuous enrollment or 31 DEC 2020
  • Treatment patterns pre- and post-initiation of Ra-223
    date_rangeTime Frame:
    Follow-up until death, end of continuous enrollment or 31 DEC 2020

Trial design

A Real-world Database Study examining Radium-223 Utilization Patterns in Men with Prostate Cancer utilizing the Surveillance, Epidemiology, and End-Results linked Medicare Database
Trial Type
Observational
Intervention Type
N/A
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A