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

NCT ID: NCT02364531

Last Updated: 2019-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 194 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-11-01

Brief Summary

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.

Detailed 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.

Conditions

Prostatic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry

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.

Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry

Intervention Type: OTHER

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.

Interventions

Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry

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.

Intervention Type: OTHER

Other Intervention Names

No Intervention

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Inc.

Locations

Calgary, Alberta, Canada

Abbotsford, British Columbia, Canada

Kamloops, British Columbia, Canada

Kelowna, British Columbia, Canada

Maple Ridge, British Columbia, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

Winnipeg, Manitoba, Canada

Dieppe, New Brunswick, Canada

Moncton, New Brunswick, Canada

St. John's, Newfoundland and Labrador, Canada

Halifax, Nova Scotia, Canada

Barrie, Ontario, Canada

Brampton, Ontario, Canada

Burlington, Ontario, Canada

Greater Sudbury, Ontario, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Mississauga, Ontario, Canada

Newmarket, Ontario, Canada

North York, Ontario, Canada

Oakville, Ontario, Canada

Oshawa, Ontario, Canada

Peterborough, Ontario, Canada

Richmond Hill, Ontario, Canada

Sault Ste. Marie, Ontario, Canada

Scarborough Village, Ontario, Canada

Thunder Bay, Ontario, Canada

Toronto, Ontario, Canada

Woodstock, Ontario, Canada

Châteauguay, Quebec, Canada

Gatineau, Quebec, Canada

Granby, Quebec, Canada

Greenfield Park, Quebec, Canada

Laval, Quebec, Canada

Montreal, Quebec, Canada

Pointe-Claire, Quebec, Canada

Québec, Quebec, Canada

Saint-Charles-Borromée, Quebec, Canada

Sherbrooke, Quebec, Canada

Val-d'Or, Quebec, Canada

Countries

Canada

Other Identifiers

212082-PCR-4020

Identifier Type: OTHER

Identifier Source: secondary_id

CR105924

Identifier Type: -

Identifier Source: org_study_id