A Multicentre Cohort Study of Patients With Advanced Prostate Cancer in Canada

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A Multicentre Cohort Study of Patients With Advanced Prostate Cancer in Canada

Condition: Prostatic Neoplasms

Intervention:

  • Other: Standard of Care

Purpose: The purpose of this study is to document the course of advanced prostate cancer in Canada in terms of disease progression, real-world treatment, and patient management.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03501173

Sponsor: Janssen Inc.

Primary Outcome Measures:

  • Measure: Time to Prostate Specific Antigen (PSA) Progression
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Time to Radiographic Evidence of Disease Progression
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Time to Skeletal-Related Events
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Time to Death
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Number of Participants with Different Primary Causes of Death
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Time to Progression from mCSPC to mCRPC in Participants with mCSPC
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Time from Biochemical Recurrence (BCR) to Nonmetastatic Castrate-Resistant Prostate Cancer (nmCRPC) and nmCRPC to mCRPC
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Number of Participants with PSA Testing from BCR to nmCRPC and nmCRPC to mCRPC, in Participants with mCRPC
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: PSA Level at Start of Androgen Deprivation Therapy (ADT) in Participants with mCRPC
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: PSA Doubling Time (PSAdt) at the Detection of Castration Resistance in Participants with mCRPC
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Time to Initiation of Subsequent Prostate Cancer Treatment
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Duration of Each Therapy
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Percentage of Participants Receiving Chemotherapy, Other Drug Treatments, or no Drug Treatment
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Time to Treatment Initiation
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Time to Dose Modification
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Number of Participants who Switch the Treatment
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Number of Participants who Discontinued the Treatment
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Most Common Sequences for Lines of Therapy in Participants with mCRPC
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Number of Participants Retreated with Docetaxel in Participants with mCRPC
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Percentage of Participant with Radiographic Imaging Modality
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Number of Days Hospitalized for Prostate Cancer or Treatment of Prostate Cancer
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Number of Visits to Emergency Department for Prostate Cancer or Treatment of Prostate Cancer
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Number of Outpatient Visits to Specialists Involved in Management of Prostate Cancer
  • Time Frame: Approximately up to 3 years
  • Safety Issue:
  • Measure: Charlson Comorbidity Index Score
  • Time Frame: Approximately up to 3 years
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: April 12, 2018

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Eligibility:

  • Age: minimum 21 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Participant must have a confirmed diagnosis of adenocarcinoma of the prostate
  • Participant must have metastatic prostate cancer, as follows: a) Metastatic castrate-sensitive prostate cancer (mCSPC): new mCSPC diagnosis in the past 3 months, documented metastatic prostate cancer, no more than 12 months of androgen deprivation therapy (ADT), no more than 3 months of systemic treatment for mCSPC (example, next generation androgen receptor targeted therapy or chemotherapy), b) Metastatic castrate-resistant prostate cancer (mCRPC): mCRPC diagnosis at any time, documented metastatic prostate cancer, documented castration resistance per Prostate Cancer Working Group 2 criteria (elevated prostate specific antigen [PSA] despite testosterone less than [<]50 nanogram per deciliter [ng/dL] [<1.7 nano moles per liter{nmol/L}]), the first treatment for mCRPC was started in the past 6 months or is scheduled to begin
  • Participant must have a life expectancy of more than 6 months
  • Participant must sign (and/or their legally acceptable representative, if applicable) a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and/or sponsor policy

Exclusion Criteria:

  • At the time of screening, participant is currently enrolled in an investigational clinical study for prostate cancer
  • Participant is currently enrolled in an observational study sponsored or managed by a Janssen company

Contact:

  • Study Contact
  • 844-434-4210

Locations:

  • Prostate Cancer Centre
  • Calgary Alberta T2V 1P9 Canada
  • University of Alberta
  • Edmonton Alberta T6G 1Z2 Canada
  • Abbotsford Regional Hospital and Cancer Centre BC Cancer Agency
  • Abbotsford British Columbia V2S 0C2 Canada
  • Vancouver General Hospital / Vancouver Prostate Centre
  • Vancouver British Columbia V5Z 1M9 Canada
  • BC Cancer Agency – Vancouver BC
  • Vancouver British Columbia V5Z 4E6 Canada
  • Cancer Care Manitoba
  • Winnipeg Manitoba R3E 0V9 Canada
  • Queen Elizabeth II – Health Sciences Centre
  • Halifax Nova Scotia B3H 2Y9 Canada
  • Research St. Joseph’s – Hamilton
  • Hamilton Ontario L8N 4A6 Canada
  • Hamilton Health Sciences Corporation
  • Hamilton Ontario L8V 5C2 Canada
  • Lawson Health Research Institute
  • London Ontario N6A 5W9 Canada
  • Credit Valley Hospital
  • Mississauga Ontario L5M 2V8 Canada
  • The Ottawa Hospital Cancer Centre
  • Ottawa Ontario K1H 8L6 Canada
  • Princess Margaret Hospital
  • Toronto Ontario M5G 2M9 Canada
  • Urology South Shore Research
  • Greenfield Park Quebec J4V 2H3 Canada
  • CHUM – Centre hospitalier universitaire de Montreal
  • Montreal Quebec H2X 0A9 Canada
  • Jewish General Hospital
  • Montreal Quebec H3T 1E2 Canada
  • CHU de Québec Université Laval
  • Quebec G1R 2J6 Canada

View trial on ClinicalTrials.gov

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