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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) Score

Brief 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

Page last updated: August 23, 2015

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