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

  • Recruiting
  • Treatment
  • Interventional
  • Randomized
  • Behavioral & Drug
  • McMaster University
  • 45 Years -


Study 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.

Intervention

Behavioral : Nutrition

Behavioral : Exercise

Behavioral : Smoking cessation

Drug : Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)

Drug : ACE inhibitor


Eligibility Requirements

info icon A man with a diagnosis of prostate cancer that is either:

info icon new (i.e. the diagnosis was made within 1 year of the enrolment visit) or

info icon treated with Androgen Deprivation Therapy for the first time within 6 months prior to the enrolment visit, or

info icon to be treated with Androgen Deprivation Therapy for the first time within 1 month after the enrolment visit

info icon 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 cance

info icon 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 ≤130mmH

Recruiting status

Recruiting

Estimated enrollment

6000

 
Study start date

Oct 21, 2015

Study end date

Dec 31, 2026

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Behavioral & Drug

Study phase

NA

Allocation

Randomized

 

Sponsor:

McMaster University

Collaborator:

Prostate Cancer Canada

Canadian Cancer Society (CCS)

Investigator:

Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC

NCT03127631

Clinic Location Investigator Distance RECRUITING STATUS Contact