Clinical trial NCT02364531: A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: Prostatic Neoplasms
Prostate Cancer
Metastatic
Observational
Abiraterone Acetate
ZYTIGA
Lead sponsor: Janssen Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-18
Enrollment: 194
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Prostate (FACT-P) Score
timeFrame: up to Week 72
measure: Brief Fatigue Inventory (BFI) Scale Score
timeFrame: up to Week 72
measure: Brief Pain Inventory - Short Form (BPI-SF) Scale Score
timeFrame: up to Week 72
measure: Current Health Satisfaction in Prostate Cancer (CHS-PCa) Questionnaire
timeFrame: up to Week 72
measure: Work Limitations Questionnaire (WLQ) Score
timeFrame: up to Week 72
measure: Prostate Specific Antigen (PSA) Level in Plasma
timeFrame: up to Week 72
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status Score
timeFrame: up to Week 72
Secondary outcomes:
measure: Barriers Encountered (Prostate Cancer Care) During Study
timeFrame: up to Week 72
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Abbotsford
country: Canada
state: British Columbia
city: Kamloops
country: Canada
state: British Columbia
city: Kelowna
country: Canada
state: British Columbia
city: Maple Ridge
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Dieppe
country: Canada
state: New Brunswick
city: Moncton
country: Canada
state: New Brunswick
city: ST. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Barrie
country: Canada
state: Ontario
city: Brampton
country: Canada
state: Ontario
city: Burlington
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: North York
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Sault Ste. Marie
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Woodstock
country: Canada
state: Ontario
city: Chateauguay
country: Canada
state: Quebec
city: Gatineau
country: Canada
state: Quebec
city: Granby
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Pointe-Claire
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: St Charles Borromee
country: Canada
state: Quebec
city: Val d'or
country: Canada
state: Quebec
city: Quebec
country: Canada
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: