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


E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe