A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting (COSMiC)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Other: Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry

Study type: Observational

Funder types: Industry

Identifiers

NCT02364531

212082-PCR-4020 (Other Identifier)

CR105924

Details and patient eligibility

About

The purpose of this 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. Safety data, levels of health care resource utilization associated with abiraterone acetate (ZYTIGA) therapy will also be prospectively collected and analyzed.

Full description

This is a non-interventional, multicenter (when more than one hospital or medical school team work on a medical research study), prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions) study. This observational study will focus on chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) participants initiating abiraterone acetate (ZYTIGA) therapy for the treatment of asymptomatic or mildly symptomatic disease. All treatment decisions will be made at the discretion of the Investigator per clinical practice and in accordance with approved local Product Monograph and treatment algorithms. The planned study duration will be three years from initial first participant enrolment. Participants will be followed for a maximum of 72 weeks from the time of initiation of abiraterone acetate (ZYTIGA) treatment, or up to the time of early study withdrawal/termination. Data will be collected in both paper-based and electronic data capture (eDC) and primarily collected for PROs and clinical outcomes. Participants' safety will be monitored throughout the study.

Enrollment: 194 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have a confirmed diagnosis of metastatic castrate-resistant prostate cancer (mCRPC) according to medical history and have rising Prostate-Specific Antigen (PSA) levels or radiographic progression (documented by previous positive bone scan or metastatic lesions identified on CT or MRI) despite ongoing conventional Androgen deprivation therapy (ADT)
• Participant (or legally accepted representative) must be able to sign an informed consent form (ICF) indicating that they understand the procedures for data collection and are willing to participate in the study
• Participant must be able to understand and complete study questionnaires
• Abiraterone Acetate (ZYTIGA) has been chosen as the treatment for mCRPC disease progression as part of standard of care
• Male participants aged greater than (>) 18 years

Exclusion criteria

• Participants currently participating in another investigational clinical study of ZYTIGA or any other investigational drug
• Participants who have received prior cytotoxic chemotherapy for prostate cancer while receiving ADT
• Participants who have any other condition that, in the opinion of the investigator, may affect the participants health or outcome of the trial (i.e. uncontrolled disease)
• Life expectancy of less than (<) 1 year
• History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer

Trial design

194 participants in 1 patient group

Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry

Description:

Participants will not receive any intervention in this study. The chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) participants who, on failing conventional androgen deprivation therapy (ADT), are prescribed to initiate Abiraterone Acetate (ZYTIGA) therapy as part of their physician's treatment approach for their asymptomatic or mildly symptomatic disease, will be observed in this study. Participants will receive standard of care therapy.

Treatment:

Other: Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry