Clinical Trial: Second Primary Cancers in Patients With Castration Resistant Prostate Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Second Primary Cancers in Patients With Castration Resistant Prostate Cancer (BOCARP)

Brief Summary: This study aims at estimating the incidence of second primary malignancies as well as the overall survival among metastasized prostate cancer (mPC) and metastasized castrate-resistant prostate cancer (mCRPC) patients not treated with radium-223-dichloride.

Detailed Summary: This study aims at estimating the incidence of second primary malignancies as well as the overall survival among mPC and mCRPC patients not treated with radium-223-dichloride. The source of data for this study will be the German Pharmacoepidemiological Research Database (GePaRD). A retrospective cohort study covering the time period from 2004 to 2013 will be conducted. The study population will comprise CRPC patients developing bone metastases. These patients will be followed up for the occurrence of second primary malignancies, end of study, or death due to any cause. As this study serves as a historical control group for a single-arm observational study, incidence rates of second primary malignancies obtained from these studies will be compared by the standardized incidence ratio using results from this study as a reference.
Sponsor: Bayer

Current Primary Outcome: Incidences of Second primary malignancies are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48. [ Time Frame: Up to 10 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Overall survival [ Time Frame: Up to 10 years ]

Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: March 4, 2016
Date Started: March 15, 2016
Date Completion:
Last Updated: May 17, 2017
Last Verified: May 2017