RECRUITING

A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

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Conditions

Prostate CancerCardiovascular DiseaseAndrogen Deprivation Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2015-10-21
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03127631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. A man with a diagnosis of prostate cancer that is either:
  2. * new (i.e. the diagnosis was made within 1 year of the enrolment visit) or
  3. * treated with Androgen Deprivation Therapy for the first time within 6 months prior to the enrolment visit, or
  4. * to be treated with Androgen Deprivation Therapy for the first time within 1 month after the enrolment visit
  1. 1. Patients will be excluded if they fulfill any of the following:
  2. 1. are unwilling to provide consent or
  3. 2. are \<45 years of age, or
  4. 3. prostate cancer was found incidentally following cystectomy for bladder cancer
  5. 2. Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
  6. 1. see a cardiologist every year, or
  7. 2. both take a statin and have systolic blood pressure ≤130mmHg

Contacts and Locations

Study Contact

Sarah Karampatos, BASc, MSc
CONTACT
905-527-4322
sarah.karampatos@phri.ca
Steven Agapay, BSc
CONTACT
905-296-5764
steve.agapay@phri.ca

Principal Investigator

Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
STUDY_DIRECTOR
McMaster University

Study Locations (Sites)

Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States

Collaborators and Investigators

Sponsor: McMaster University

  • Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC, STUDY_DIRECTOR, McMaster University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-10-21
Study Completion Date2025-12

Study Record Updates

Study Start Date2015-10-21
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Androgen Deprivation Therapy

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Cardiovascular Disease