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Prostatic NeoplasmsCOSMiCNCT02364531

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

An observational study of Prostatic Neoplasms, run by Janssen Inc. at 41 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry
How many people
194 participants
Where
41 sitesCanada
Study dates
30 Sep 2014to 1 Nov 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) participants who were prescribed Abiraterone Acetate (ZYTIGA) will be enrolled.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

41 sites in 1 country.

41 sites in 1 country

Canada41 sites

  • Study site

    Abbotsford British Columbia, British Columbia

  • Study site

    Barrie, Ontario

  • Study site

    Brampton, Ontario

  • Study site

    Burlington, Ontario

  • Study site

    Calgary, Alberta

  • Study site

    Châteauguay, Quebec

  • Study site

    Dieppe, New Brunswick

  • Study site

    Gatineau, Quebec

  • Study site

    Granby, Quebec

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Greenfield Park, Quebec

  • Study site

    Halifax, Nova Scotia

  • Study site

    Hamilton, Ontario

  • Study site

    Kamloops, British Columbia

  • Study site

    Kelowna, British Columbia

  • Study site

    Laval, Quebec

  • Study site

    London, Ontario

  • Study site

    Maple Ridge, British Columbia

  • Study site

    Mississauga, Ontario

  • Study site

    Moncton, New Brunswick

  • Study site

    Montreal, Quebec

  • Study site

    Newmarket, Ontario

  • Study site

    North York, Ontario

  • Study site

    Oakville, Ontario

  • Study site

    Oshawa, Ontario

  • Study site

    Peterborough, Ontario

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Richmond Hill, Ontario

  • Study site

    Saint-Charles-Borromée, Quebec

  • Study site

    Sault Ste. Marie, Ontario

  • Study site

    Scarborough Village, Ontario

  • Study site

    Sherbrooke, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Thunder Bay, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Val-d'Or, Quebec

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

  • Study site

    Winnipeg, Manitoba

  • Study site

    Woodstock, Ontario

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry
Keywords
Prostatic Neoplasms, Prostate Cancer, Metastatic, Observational, Abiraterone Acetate, ZYTIGA
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone Acetate (ZYTIGA): Prostate Cancer RegistryOther

    Also called No Intervention

    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.

Study groups in NCT02364531
Study groupRoleWhat they receive
Abiraterone Acetate (ZYTIGA): Prostate Cancer RegistryParticipants 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.
Receives: Other: Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to Week 72

  2. 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.

    Measured: up to Week 72

  3. 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.

    Measured: up to Week 72

  4. 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.

    Measured: up to Week 72

  5. 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.

    Measured: up to Week 72

  6. Prostate Specific Antigen (PSA) Level in Plasma

    Prostate Specific Antigen (PSA) Level in Plasma at Week 72 will be assessed.

    Measured: up to Week 72

  7. 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

    Measured: up to Week 72

Secondary outcomes (1)

  1. Barriers Encountered (Prostate Cancer Care) During Study

    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.

    Measured: up to Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2015 (estimated)
  2. Study start30 Sep 2014
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364531
Sponsor's protocol ID
CR105924
Other IDs
212082-PCR-4020
Acronym
COSMiC
Status last verified
Dec 2019
First submitted
10 Feb 2015
Last updated
6 Dec 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Neoplasms, run by Janssen Inc. at 41 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score (time frame: up to Week 72). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.

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