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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • 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
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • New Brunswick
      • Dieppe, New Brunswick, Canada
      • Moncton, New Brunswick, Canada
    • Newfoundland and Labrador
      • ST. John's, Newfoundland and Labrador, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Barrie, Ontario, Canada
      • Brampton, Ontario, Canada
      • Burlington, 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, Ontario, Canada
      • Sudbury, Ontario, Canada
      • Thunder Bay, Ontario, Canada
      • Toronto, Ontario, Canada
      • Woodstock, Ontario, Canada
    • Quebec
      • Chateauguay, Quebec, Canada
      • Gatineau, Quebec, Canada
      • Granby, Quebec, Canada
      • Greenfield Park, Quebec, Canada
      • Laval, Quebec, Canada
      • Montreal, Quebec, Canada
      • Pointe-Claire, Quebec, Canada
      • Sherbrooke, Quebec, Canada
      • St Charles Borromee, Quebec, Canada
      • Val d'or, Quebec, Canada

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Other Names:
  • No Intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score
Time Frame: up to Week 72
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
Time Frame: up to Week 72
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
Time Frame: up to Week 72
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
Time Frame: up to Week 72
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
Time Frame: up to Week 72
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
Time Frame: up to Week 72
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
Time Frame: up to Week 72
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Barriers Encountered (Prostate Cancer Care) During Study
Time Frame: up to Week 72
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.
up to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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