A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
- Conditions
- Prostate CancerCardiovascular Disease
- Interventions
- Behavioral: NutritionBehavioral: ExerciseBehavioral: Smoking cessationDrug: 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 6000
- 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
-
Patients will be excluded if they fulfill any of the following:
- are unwilling to provide consent or
- are <45 years of age, or
- prostate cancer was found incidentally following cystectomy for bladder cancer
-
Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
- see a cardiologist every year, or
- 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
Centro Médico São Francisco
🇧🇷Curitiba, Paraná, Brazil
Instituto De Medicina Integral Prof. Fernando Figueira - IMIP
🇧🇷Recife, Pernambuco, 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, Sao 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
Integral Pesquisa e Ensino
🇧🇷Votuporanga, São Paulo, Brazil
Instituto Nacional de Cardiologia
🇧🇷Rio De Janeiro, Brazil
Santa Casa de São Paulo (IPITEC)
🇧🇷São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
🇧🇷São Paulo, Brazil
Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro
🇧🇷São Paulo, Brazil
Marina Leonardo
🇧🇷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, Brazil
Hospital Santa Marcelina
🇧🇷São Paulo, Brazil
Instituto D'Or de Pesquisa e Ensino
🇧🇷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
University Hospital of Montreal
🇨🇦Montreal, Quebec, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
McGill University
🇨🇦Montréal, Quebec, Canada
Laval University
🇨🇦Quebec City, Quebec, Canada
Centre Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Hospital Universitario San Ignacio
🇨🇴Bogotá, Cundinamarca, Colombia
FOSCAL
🇨🇴Floridablanca, Santander, Colombia
Fundacio Valle de Lili
🇨🇴Cali, Valle del Cauca, Colombia
Heart Institute - Holon Medical Center
🇮🇱Holon, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Tel-Aviv Sourasky Medical Centre
🇮🇱Tel Aviv, Israel
Istanbul University
🇹🇷Istanbul, Turkey