A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
COSMiC
2 other identifiers
observational
194
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2014
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedDecember 6, 2019
December 1, 2019
4.1 years
February 10, 2015
December 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score
The FACT-P consists of the FACT-General (FACT-G) and a prostate cancer subscale. The FACT-G contains a 27-item questionnaire and is composed of 4 subscales of health-related quality-of-life: physical well-being, social/family well-being, emotional well-being, and functional well-being. Each Item is scored on a scale of 0 (Not at all) to 4 (Very much). All Items on a sub-scale will be averaged to derive the sub-scale score.The prostate cancer subscale is composed of 12 items, related to prostate-specific questions, which include sexuality, bowel/bladder function, and pain. The FACT-P questionnaire has a 7-day recall, and takes approximately 15 minutes to complete. Each Item is scored on a scale of 0 (Not at all) to 4 (Very much). All Items on a sub-scale will be averaged to derive the sub-scale score.
up to Week 72
Brief Fatigue Inventory (BFI) Scale Score
The BFI assesses the severity of fatigue and the impact of fatigue on daily functioning. BFI measures the severity of fatigue and the impact of fatigue on daily functioning in the past 24 hours. BFI is a 4 item questionnaire. Each item is assessed on a 11-point scale, ranges from 0 (No Fatigue) to 10 (As bad as you can imagine). Average from all 4 items will be used to derive the final score.
up to Week 72
Brief Pain Inventory - Short Form (BPI-SF) Scale Score
The BPI-SF measures severity of pain, impact of pain on daily function, locations of pain, pain medications, and amount of pain relief in the past 24 hours or the past week. The BPI- SF includes 4 items measuring the intensity of pain which make up the pain intensity subscales, assessed using 11-point numerical rating scales from "0" = no pain to "10" = pain as bad as you can imagine; 7 items that assess how much pain has interfered with 7 daily activities which make up the pain interference subscale, assessed on a scale of 0, "Does not interfere" to 10, "completely interferes." This subscale is typically scored as the mean of the 7 interference items; An additional item on the extent of pain relief.
up to Week 72
Current Health Satisfaction in Prostate Cancer (CHS-PCa) Questionnaire
The CHS-PCa is an exploratory questionnaire that includes 9 questions to assess participant satisfaction with their current status. Each question has 7 response categories corresponding to strongly agree, disagree, somewhat disagree, neither agree nor disagree, somewhat agree, agree and strongly agree.
up to Week 72
Work Limitations Questionnaire (WLQ) Score
The WLQ measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss. The WLQ items ask respondents to rate their level of difficulty or ability to perform specific job demands. Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on- the-job.
up to Week 72
Prostate Specific Antigen (PSA) Level in Plasma
Prostate Specific Antigen (PSA) Level in Plasma at Week 72 will be assessed.
up to Week 72
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (greater than \[\>\]50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair \>50 percent (%) of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status
up to Week 72
Secondary Outcomes (1)
Barriers Encountered (Prostate Cancer Care) During Study
up to Week 72
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) participants who were prescribed Abiraterone Acetate (ZYTIGA) will be enrolled.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Inc.lead
Study Sites (41)
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Abbotsford, British Columbia, Canada
Unknown Facility
Kamloops, British Columbia, Canada
Unknown Facility
Kelowna, British Columbia, Canada
Unknown Facility
Maple Ridge, British Columbia, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Dieppe, New Brunswick, Canada
Unknown Facility
Moncton, New Brunswick, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Barrie, Ontario, Canada
Unknown Facility
Brampton, Ontario, Canada
Unknown Facility
Burlington, Ontario, Canada
Unknown Facility
Greater Sudbury, Ontario, Canada
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
London, Ontario, Canada
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Mississauga, Ontario, Canada
Unknown Facility
Newmarket, Ontario, Canada
Unknown Facility
North York, Ontario, Canada
Unknown Facility
Oakville, Ontario, Canada
Unknown Facility
Oshawa, Ontario, Canada
Unknown Facility
Peterborough, Ontario, Canada
Unknown Facility
Richmond Hill, Ontario, Canada
Unknown Facility
Sault Ste. Marie, Ontario, Canada
Unknown Facility
Scarborough Village, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
Unknown Facility
Woodstock, Ontario, Canada
Unknown Facility
Châteauguay, Quebec, Canada
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Gatineau, Quebec, Canada
Unknown Facility
Granby, Quebec, Canada
Unknown Facility
Greenfield Park, Quebec, Canada
Unknown Facility
Laval, Quebec, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Pointe-Claire, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Saint-Charles-Borromée, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Unknown Facility
Val-d'Or, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Inc. Clinical Trial
Janssen Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 18, 2015
Study Start
September 30, 2014
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
December 6, 2019
Record last verified: 2019-12