check_circleStudy Completed
Prostatic neoplasms
Bayer Identifier:
18673
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US
Trial purpose
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.
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.
Key Participants Requirements
Sex
MaleAge
65 - N/ATrial summary
Enrollment Goal
2234Trial Dates
May 2016 - May 2018Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Waltham, United States |
Primary Outcome
- Incidence rate of second primary malignancydate_rangeTime Frame:Retrospective analysis between 1-Jan-2000 and 31-Dec-2013enhanced_encryptionNoSafety Issue:
- Incidence rates of skeletal-related eventsdate_rangeTime Frame:Retrospective analysis between 1-Jan-2000 and 31-Dec-2013enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Proportion with a history of bone metastasis at cohort entrydate_rangeTime Frame:Retrospective analysis between 1-Jan-2000 and 31-Dec-2013enhanced_encryptionNoSafety Issue:
- Proportion who met the definition of castration based solely on Part D datadate_rangeTime Frame:Retrospective analysis between 1-Jan-2000 and 31-Dec-2013enhanced_encryptionNoSafety Issue:
- Overall survivaldate_rangeTime Frame:Retrospective analysis between 1-Jan-2000 and 31-Dec-2013enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A