- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02364531
A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting (COSMiC)
December 5, 2019 updated by: Janssen Inc.
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
194
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada
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Alberta
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Calgary, Alberta, Canada
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British Columbia
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Abbotsford, British Columbia, Canada
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Kamloops, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Maple Ridge, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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New Brunswick
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Dieppe, New Brunswick, Canada
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Moncton, New Brunswick, Canada
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Newfoundland and Labrador
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ST. John's, Newfoundland and Labrador, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Barrie, Ontario, Canada
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Brampton, Ontario, Canada
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Oshawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Scarborough, Ontario, Canada
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Sudbury, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Woodstock, Ontario, Canada
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Quebec
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Chateauguay, Quebec, Canada
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Gatineau, Quebec, Canada
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Granby, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Sherbrooke, Quebec, Canada
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St Charles Borromee, Quebec, Canada
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Val d'or, Quebec, Canada
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) participants who were prescribed Abiraterone Acetate (ZYTIGA) will be enrolled.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score
Time Frame: up to Week 72
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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.
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up to Week 72
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Brief Fatigue Inventory (BFI) Scale Score
Time Frame: up to Week 72
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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.
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up to Week 72
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Brief Pain Inventory - Short Form (BPI-SF) Scale Score
Time Frame: up to Week 72
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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.
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up to Week 72
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Current Health Satisfaction in Prostate Cancer (CHS-PCa) Questionnaire
Time Frame: up to Week 72
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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.
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up to Week 72
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Work Limitations Questionnaire (WLQ) Score
Time Frame: up to Week 72
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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.
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up to Week 72
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Prostate Specific Antigen (PSA) Level in Plasma
Time Frame: up to Week 72
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Prostate Specific Antigen (PSA) Level in Plasma at Week 72 will be assessed.
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up to Week 72
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Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Time Frame: up to Week 72
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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
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up to Week 72
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Barriers Encountered (Prostate Cancer Care) During Study
Time Frame: up to Week 72
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At the end of study, each participating investigator, as part of the close out activities, will be interviewed to identify the barriers which were encountered to enrolling participants in the study and also assess if barriers and/or participant flow were changed during the course of the study.
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up to Week 72
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2014
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
February 10, 2015
First Submitted That Met QC Criteria
February 17, 2015
First Posted (Estimate)
February 18, 2015
Study Record Updates
Last Update Posted (Actual)
December 6, 2019
Last Update Submitted That Met QC Criteria
December 5, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Neoplastic Processes
- Prostatic Neoplasms
- Neoplasm Metastasis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Abiraterone Acetate
Other Study ID Numbers
- CR105924
- 212082-PCR-4020 (Other Identifier: Janssen Inc.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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