COSMiC details
DOI:
https://doi.org/10.5489/cuaj.2788Abstract
A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting. The COSMiC Prospective Prostate Cancer Registry.
The purpose of this non-interventional, prospective, observational study is to temporally evaluate the impact of abiraterone acetate (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population.
Study participants must have a confirmed diagnosis of mCRPC according to medical history and have rising PSA levels or radiographic progression (documented by previous positive bone scan or metastatic lesions identified on CT or MRI) despite ongoing conventional ADT.
Study participants will complete Quality of Life and Patient Satisfaction questionnaires longitudinally at defined time points. Safety and efficacy data, as well as levels of health care resource utilization associated with ZYTIGA therapy, will also be prospectively collected and analyzed.
Once enrolled, study participants will be followed for a maximum of 72 weeks from the time of initiation of ZYTIGA treatment, or up to the time of early study withdrawal/termination.
For additional information please contact Richard K. Plante at rplante@its.jnj.com
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