NCT02702908

Second Primary Cancers in Patients With Castration Resistant Prostate Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,442 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
OTHER	—	Historical Reference group.

Timeline

• Start date: 2016-03-15
• Primary completion: 2017-10-20
• Completion: 2017-10-20
• First posted: 2016-03-09
• Last updated: 2018-01-19

Locations

1 site across 1 country: Germany