Study 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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Where to participate

Status	Institution	Location
Completed	Many locations	Many locations, USA

Primary Outcome

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

Secondary Outcome

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