Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32030
• EU PAS number:
  EUPAS13602
• Study ID:
  32030
• Official title and acronym:
  Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study.Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo. To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Study timelines

Date when funding contract was signed

Actual: 04/11/2015

Study start date

Planned: 15/06/2016

Actual: 20/05/2016

Date of final study report

Planned: 28/07/2017

Actual: 05/07/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

18673_Study Protocol_V1.0_2016-03-09_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable