The Role of Androgen Deprivation Therapy In Cardiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC1) & A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICAL PC2)


Condition: Prostate Cancer, Cardiovascular Disease

Intervention:

  • Behavioral: Nutrition
  • Behavioral: Exercise
  • Behavioral: Smoking cessation
  • Drug: Antiplatelet agent, such as Aspirin, or other low-dose antiplatelet agent
  • Drug: Statin, such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
  • Drug: ACE inhibitor

Purpose: RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03127631

Sponsor: McMaster University

Primary Outcome Measures:

  • Measure: Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
  • Time Frame: 3-5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - CV Death
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Stroke
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Heart Failure
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism
  • Time Frame: 3-5 years
  • Safety Issue:

Estimated Enrollment: 6000

Study Start Date: October 2015

Eligibility:

  • Age: minimum 45 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. A man with a diagnosis of prostate cancer that is either:
  • new (i.e. the diagnosis was made within 1 year of the enrolment visit) or
  • treated with Androgen Deprivation Therapy for the first time within 6 months prior to the enrolment visit, or
  • to be treated with Androgen Deprivation Therapy for the first time within 1 month after the enrolment visit

Exclusion Criteria:

  • 1. Unwilling to provide consent, or 2. Are <45 years of age 3. Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
  • see a cardiologist every year, or
  • are undertaking all of the following:
  • aspirin use, and
  • statin use, and
  • systolic blood pressure ≤130mmHg

Contact:

  • Sarah Karampatos, BASc, MSc
  • 905-527-4322 Ext. 40506

Locations:

  • Vancouver General Hospital
  • Vancouver British Columbia V5Z 1M9 Canada
  • William Osler Health System
  • Brampton Ontario L6R 3J7 Canada
  • St. Joseph's Healthcare
  • Hamilton Ontario L8N4A6 Canada
  • Juravinski Cancer Centre
  • Hamilton Ontario L8V1C3 Canada
  • Queen's University
  • Kingston Ontario K7L 3J7 Canada
  • Grand River Hospital, Grand River Regional Cancer Centre
  • Kitchener Ontario N2G 1G3 Canada
  • London Health Sciences Centre
  • London Ontario N6A 5W9 Canada
  • London Health Sciences, Victoria Hospital
  • London Ontario N6A 5W9 Canada
  • Niagara Health, St. Catharines Site
  • Niagara Ontario L2S 0A9 Canada
  • Ottawa Hospital Research Institute
  • Ottawa Ontario K1H 8L6 Canada
  • Sunnybrook Health Sciences Centre
  • Toronto Ontario M4N 3M5 Canada
  • University Health Network, Princess Margaret Cancer Centre
  • Toronto Ontario M5G 2C1 Canada
  • University Hospital of Montreal
  • Montreal Quebec H2X 0A9 Canada
  • Jewish General Hospital
  • Montreal Quebec H3T 1E2 Canada
  • McGill University
  • Montréal Quebec H3A 0G4 Canada
  • Laval University
  • Quebec City Quebec G1V 0A6 Canada

View trial on ClinicalTrials.gov