A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
Information source: Janssen Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Neoplasms
Intervention: Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Janssen Inc. Official(s) and/or principal investigator(s): Janssen Inc. Clinical Trial, Study Director, Affiliation: Janssen Inc.
Overall contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com
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.
Clinical Details
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
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Functional Assessment of Cancer Therapy - Prostate (FACT-P) ScoreBrief Fatigue Inventory (BFI) Scale Score EuroQoL-5 Health Status Index Outcome Brief Pain Inventory - Short Form (BPI-SF) Scale Score Current Health Satisfaction in Prostate Cancer (CHS-PCa) Questionnaire Work Limitations Questionnaire (WLQ) Score Prostate Specific Antigen (PSA) Level in Plasma Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Secondary outcome: Barriers Encountered (Prostate Cancer Care) During Study
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 via electronic data capture (eDC) and
primarily collected for PROs and clinical outcomes. Participants' safety will be monitored
throughout the study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com
Greenfield Park, Canada; Recruiting
Quebec, Canada; Not yet recruiting
Calgary, Alberta, Canada; Recruiting
Abbotsford, British Columbia, Canada; Not yet recruiting
Cranbrook, British Columbia, Canada; Not yet recruiting
Kamloops, British Columbia, Canada; Not yet recruiting
Kelowna, British Columbia, Canada; Not yet recruiting
Maple Ridge, British Columbia, Canada; Not yet recruiting
Port Alberni, British Columbia, Canada; Not yet recruiting
Victoria, British Columbia, Canada; Recruiting
Winnipeg, Manitoba, Canada; Not yet recruiting
Dieppe, New Brunswick, Canada; Recruiting
Moncton, New Brunswick, Canada; Not yet recruiting
St. John'S, Newfoundland and Labrador, Canada; Not yet recruiting
Barrie, Ontario, Canada; Not yet recruiting
Barrie, Ontario, Canada; Recruiting
Brampton, Ontario, Canada; Recruiting
Burlington, Ontario, Canada; Recruiting
North York, Ontario, Canada; Recruiting
Oakville, Ontario, Canada; Recruiting
Peterborough, Ontario, Canada; Not yet recruiting
Scarborough, Ontario, Canada; Recruiting
Toronto, Ontario, Canada; Not yet recruiting
Chateauguay, Quebec, Canada; Not yet recruiting
Chicoutimi, Quebec, Canada; Not yet recruiting
Gatineau, Quebec, Canada; Not yet recruiting
Laval, Quebec, Canada; Recruiting
Montreal, Quebec, Canada; Not yet recruiting
Pointe-Claire, Quebec, Canada; Recruiting
Sherbrooke, Quebec, Canada; Not yet recruiting
St Charles Borromee, Quebec, Canada; Recruiting
Saskatoon, Saskatchewan, Canada; Not yet recruiting
Additional Information
To learn how to participate in this trial please click here.
Starting date: September 2014
Last updated: August 7, 2015
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