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

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.

Conditions

  • Prostate Cancer
  • Cardiovascular Disease

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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. Patients will be excluded if they fulfill any of the following: 1. are unwilling to provide consent or 2. are <45 years of age, or 3. prostate cancer was found incidentally following cystectomy for bladder cancer 2. Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they: 1. see a cardiologist every year, or 2. both take a statin and have systolic blood pressure ≤130mmHg

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Randomized - Intervention 		The intervention will consist of a systematic cardiovascular and lifestyle risk factor modification strategy, including dietary and exercise advice, advice to quit smoking, and the prescription of open-label statins, ACE-I, and other antihypertensive medications where appropriate.
  • Behavioral: Nutrition
    Standardized advice on healthy diet practices.
  • Behavioral: Exercise
    Standardized advice on exercise including strength training and resistance training exercises.
  • Behavioral: Smoking cessation
    Advice to quit smoking, if applicable, and on available aids to quit smoking,
  • Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
    Prescription for a low to moderate dose statin, such as simvastatin 10-40mg daily, atorvastatin 10-40mg daily, rosuvastatin 5-20mg daily or pravastatin 10-40mg daily.
  • Drug: ACE inhibitor
    Prescription for an ACE-I (preferable) or an angiotensin receptor blocker for baseline systolic blood pressure greater >130mmHg, or other blood pressure lowering medication as applicable.
No Intervention
Randomized - Control 		The control will consist of usual clinical care, which may include a referral to a cardiologist or internist, or the use of treatments included in the intervention as clinically indicated, if part of the treating physician's standard practice.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Terry Christenson
tchristenson3@kumc.edu

More Details

Status
Recruiting
Sponsor
McMaster University

Study Contact

Sarah Karampatos, BASc, MSc
905-527-4322
sarah.karampatos@phri.ca

Detailed Description

RADICAL PC describes two prospective studies, one of which is embedded in the other. RADICAL PC1 is a prospective cohort study of men within one year of their first diagnosis of prostate cancer, or treated with Androgen Deprivation Therapy for the first time within 6 months prior to enrollment visit, or to be treated with Androgen Deprivation Therapy for the first time within one month after the enrollment visit. Its goal will be to identify factors associated with the development of cardiovascular disease among men with prostate cancer, with a particular focus on Androgen Deprivation Therapy. RADICAL PC2 is a randomized, controlled trial embedded in RADICAL PC1. RADICAL PC2 will test a systematic approach to modifying cardiovascular and lifestyle risk factors in men within one year of their first diagnosis of prostate cancer, or treated with Androgen Deprivation Therapy for the first time within 6 months prior to enrollment visit, or to be treated with Androgen Deprivation Therapy for the first time within one month after the enrollment visit.