A Study for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

NCT03127631 · tracked via the Priya Life Science Brazil tracker

Sponsor

McMaster University

Phase

Not applicable

Started

2015-10-21

Last updated

2026-07-02

Condition(s) studied

Prostate CancerCardiovascular Disease

Investigational drug(s) / intervention(s)

NutritionExerciseSmoking cessationStatin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)ACE inhibitor

Nutrition: Standardized advice on healthy diet practices.

Exercise: Standardized advice on exercise including strength training and resistance training exercises.

Smoking cessation: Advice to quit smoking, if applicable, and on available aids to quit smoking,

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.

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.

Study 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.

Eligibility

Sex

MALE

Min age

45 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Hierarchical composite of cardiovascular death, myocardial infarction, stroke, heart failure, cholesterol control (defined as total cholesterol ≤4mmol/L) and systolic blood pressure control (defined as systolic blood pressure ≤130mmHg). — 3-5 years
Hierarchical composite of cardiovascular death, myocardial infarction, stroke, heart failure, cholesterol control (defined as total cholesterol ≤4mmol/L) and systolic blood pressure control (defined as systolic blood pressure ≤130mmHg).
Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure. — 3-5 years
Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.

Trial sites (61)

Facility	City	Region
Georgia Cancer Center at Augusta University	Augusta	Georgia
University of Kansas Medical Center	Kansas City	Kansas
University of Pennsylvania	Philadelphia	Pennsylvania
UT Southwestern Medical Center	Dallas	Texas
Westmead Hospital	Westmead	New South Wales
Royal Adelaide Hospital	Adelaide	South Australia
Flinders Medical Center	Adelaide	South Australia
Centro de Pesquisa Clínica do Brasil	Brasília	Federal District
Hospital Felício Rocho	Belo Horizonte	Minas Gerais
Universidade Federal do Triângulo Mineiro	Uberaba	Minas Gerais
Sociedade Hospitalar Angelina Caron	Campina Grande do Sul	Paraná
Nucleo de Pesquisa Clinica Hospital do Rocio	Campo Largo	Paraná
Centro Médico São Francisco	Curitiba	Paraná
Instituto De Medicina Integral Prof. Fernando Figueira - IMIP	Recife	Pernambuco
Instituto Nacional de Cardiologia	Rio de Janeiro	Rio de Janeiro
Hospital de Caridade de Ijuí	Ijuí	Rio Grande do Sul
Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Irmandade Da Santa Casa De Misericórdia De Porto Alegre	Porto Alegre	Rio Grande do Sul
Hospital Mae de Deus	Porto Alegre	Rio Grande do Sul
Hospital Municipal de Barueri	Barueri	São Paulo
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP	Botucatu	São Paulo
Hospital Universitário São Francisco na Providência de Deus	Bragança Paulista	São Paulo
Fundacao Doutor Amaral Carvalho	Jaú	São Paulo
Fundação Faculdade Regional de Medicina de São José do Rio Preto	São José do Rio Preto	São Paulo
Santa Casa de São Paulo (IPITEC)	São Paulo	São Paulo
Hospital Alemao Oswaldo Cruz	São Paulo	São Paulo
Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro	São Paulo	São Paulo
Núcleo de Pesquisa e Ensino da Rede São Camilo	São Paulo	São Paulo
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor)	São Paulo	São Paulo
Hospital Santa Marcelina	São Paulo	São Paulo
Instituto D'Or de Pesquisa e Ensino	São Paulo	São Paulo
Integral Pesquisa e Ensino	Votuporanga	São Paulo
Vancouver General Hospital	Vancouver	British Columbia
St. Joseph's Healthcare	Hamilton	Ontario
Juravinski Cancer Centre	Hamilton	Ontario
Queen's University	Kingston	Ontario
Grand River Hospital, Grand River Regional Cancer Centre	Kitchener	Ontario
London Health Sciences Centre	London	Ontario
London Health Sciences, Victoria Hospital	London	Ontario
Niagara Health, St. Catharines Site	Niagara	Ontario

+ 21 more sites — see the full list on the official registry below.

More McMaster University trials in Brazil

Surveillance AFter Extremity Tumor surgerY Active, not recruiting

Other trials for the same condition

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting

Phase III Radium 223 mCRPC-PEACE III Active, not recruiting

EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction Active, not recruiting

A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer Active, not recruiting

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03127631 on ClinicalTrials.gov ↗ ← All trials in Brazil