RecruitingNot ApplicableNCT03127631

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

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)

Sponsor

McMaster University

Enrollment

6,000 participants

Start Date

Oct 21, 2015

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Cardiovascular Disease

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: MALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a proactive program to address heart health and lifestyle factors improves outcomes for men newly diagnosed with prostate cancer, especially those starting hormonal therapy (which can raise cardiovascular risk). You may be eligible if: you are a man diagnosed with prostate cancer within the past year; or you are starting hormonal therapy (androgen deprivation therapy) for the first time within 6 months before or 1 month after enrolling. You may NOT be eligible if: you are unwilling to give consent; you are under 45 years old; or your prostate cancer was discovered incidentally after bladder surgery. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNutrition

Standardized advice on healthy diet practices.

BEHAVIORALExercise

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

BEHAVIORALSmoking cessation

Advice to quit smoking, if applicable, and on available aids to quit smoking,

DRUGStatin (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.

DRUGACE 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.

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

Brasília, Federal District, 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

Centro Médico São Francisco

Curitiba, Paraná, Brazil

Instituto De Medicina Integral Prof. Fernando Figueira - IMIP

Recife, Pernambuco, Brazil

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital de Caridade de Ijuí

Ijuí, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Irmandade Da Santa Casa De Misericórdia De Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Municipal de Barueri

Barueri, São Paulo, Brazil

Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP

Botucatu, São Paulo, Brazil

Hospital Universitário São Francisco na Providência de Deus

Bragança Paulista, São Paulo, Brazil

Fundacao Doutor Amaral Carvalho

Jaú, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Santa Casa de São Paulo (IPITEC)

São Paulo, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro

São Paulo, São Paulo, Brazil

Marina Leonardo

São Paulo, São Paulo, Brazil

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor)

São Paulo, São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Instituto D'Or de Pesquisa e Ensino

São Paulo, São Paulo, Brazil

Integral Pesquisa e Ensino

Votuporanga, São Paulo, Brazil

Vancouver General Hospital

Vancouver, British Columbia, Canada

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Queen's University

Kingston, Ontario, Canada

Grand River Hospital, Grand River Regional Cancer Centre

Kitchener, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

London Health Sciences, Victoria Hospital

London, Ontario, Canada

Niagara Health, St. Catharines Site

Niagara, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

University Hospital of Montreal

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Laval University

Québec, Quebec, Canada

Centre Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Hospital Universitario San Ignacio

Bogotá, Cundinamarca, Colombia

FOSCAL

Floridablanca, Santander Department, Colombia

Fundacio Valle de Lili

Cali, Valle del Cauca Department, Colombia

Heart Institute - Holon Medical Center

Holon, Israel

Rabin Medical Center

Petah Tikva, Israel

Tel-Aviv Sourasky Medical Centre

Tel Aviv, Israel

Istanbul University

Istanbul, Turkey (Türkiye)

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