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

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Cardiovascular Disease
• Interventions: Behavioral: Nutrition; Behavioral: Exercise; Behavioral: Smoking cessation; Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin); Drug: ACE inhibitor

• Registration Number: NCT03127631
• Lead Sponsor: McMaster University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2015-10-21
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 6000

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Randomized - Intervention	Nutrition	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.
Randomized - Intervention	Exercise	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.
Randomized - Intervention	Smoking cessation	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.
Randomized - Intervention	Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)	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.
Randomized - Intervention	ACE inhibitor	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.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.	3-5 years	The primary efficacy outcome is the occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization.

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction	3-5 years	Myocardial infarction.
Secondary Efficacy Outcome - Event Outcome - Heart Failure	3-5 years	Heart failure.
Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism	3-5 years	Venous Thromboembolism.
Secondary Efficacy Outcome - Event Outcome - CV Death	3-5 years	Cardiovascular death.
Secondary Efficacy Outcome - Composite of Death, MI, Stroke	3-5 years	The composite of cardiovascular death, myocardial infarction, or stroke.
Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.	3-5 years	The occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure.
Secondary Efficacy Outcome - Event Outcome - Stroke	3-5 years	Stroke.
Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.	3-5 years	The composite of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina.

Trial Locations

Locations (54)

Georgia Cancer Center at Augusta University; 🇺🇸 Augusta, Georgia, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Flinders Medical Center; 🇦🇺 Adelaide, South Australia, Australia

Centro de Pesquisa Clínica do Brasil; 🇧🇷 Brasilia, DF, Brazil

Hospital Felício Rocho; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Universidade Federal do Triângulo Mineiro; 🇧🇷 Uberaba, Minas Gerais, Brazil

Sociedade Hospitalar Angelina Caron; 🇧🇷 Campina Grande Do Sul, Paraná, Brazil

Nucleo de Pesquisa Clinica Hospital do Rocio; 🇧🇷 Campo Largo, Paraná, Brazil

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