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NCT03127631 | RECRUITING | Prostate Cancer


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

Condition or disease

Prostate Cancer

Cardiovascular Disease

Intervention/treatment

Nutrition

Exercise

Smoking cessation

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

ACE inhibitor

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 6000 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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)
Actual Study Start Date : 2015-10-21
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT03127631


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Georgia

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States, 30912

RECRUITING

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

RECRUITING

Australia, New South Wales

Westmead Hospital

Westmead, New South Wales, Australia, 2145

RECRUITING

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

RECRUITING

Australia, South Australia

Flinders Medical Center

Adelaide, South Australia, Australia, 5042

RECRUITING

Brazil, DF

Clinical Research Center of Brazil

Brasilia, DF, Brazil, 71625175

RECRUITING

Brazil, Minas Gerais

Felício Rocho Hospital

Belo Horizonte, Minas Gerais, Brazil, 30110-934

RECRUITING

Brazil, Minas Gerais

Federal University of Triangulo Mineiro

Uberaba, Minas Gerais, Brazil, 38025-260

RECRUITING

Brazil, Paraná

Angelina Caron Hospital Society

Campina Grande do Sul, Paraná, Brazil, 83.430-000

RECRUITING

Brazil, Paraná

Clinical Research Nucleus Hospital do Rocio

Long field, Paraná, Brazil,

RECRUITING

Brazil, Paraná

Medical Center São Francisco

Curitiba, Paraná, Brazil, 80810-050

RECRUITING

Brazil, Pernambuco

Institute of Integral Medicine Fernando Figueira - Imip

Recife, Pernambuco, Brazil, 50.070-902

RECRUITING

Brazil, Rio Grande do Sul

Ijuí Charity Hospital

Ijuí, Rio Grande do Sul, Brazil, 98700-000

RECRUITING

Brazil, Rio Grande do Sul

Porto Alegre Clinic Hospital

Porto Alegre, Rio Grande do Sul, Brazil, 90035-903

RECRUITING

Brazil, Rio Grande do Sul

Brotherhood of the Holy House of Mercy of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90050-170

RECRUITING

Brazil, Rio Grande do Sul

MAE OF GOD HOSPITAL

Porto Alegre, Rio Grande do Sul, Brazil, 90840-440

RECRUITING

Brazil, São Paulo

Barueri Municipal Hospital

Barueri, São Paulo, Brazil, 06463-320

RECRUITING

Brazil, São Paulo

Faculty of Medicine, Paulista State University - Botucatu Campus - UNESP

Bottled, São Paulo, Brazil, 18618-687

RECRUITING

Brazil, São Paulo

São Francisco University Hospital in the Providence of God

Bragança Paulista, São Paulo, Brazil, 12.916-542

RECRUITING

Brazil, São Paulo

Foundation Doctor Amaral Carvalho

Jaú, São Paulo, Brazil, 17210080

RECRUITING

Brazil, São Paulo

Regional College of Medicine Foundation of São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil, 15090-000

RECRUITING

Brazil, São Paulo

Integral Research and Teaching

Votuporanga, São Paulo, Brazil, 15501-405

RECRUITING

Brazil,

National Institute of Cardiology

Rio de Janeiro, Brazil, 22240-006

RECRUITING

Brazil,

Santa Casa de São Paulo (Ipitec)

São Paulo, Brazil, 01223-001

RECRUITING

Brazil,

Hospital Germany Oswaldo Cruz

São Paulo, Brazil, 01327001

RECRUITING

Brazil,

Japanese-Brazilian Beneficence of São Paulo. Nipo-Brazilian Hospital

São Paulo, Brazil, 02189-000

RECRUITING

Brazil,

Marina Leonardo

São Paulo, Brazil, 04014-002

RECRUITING

Brazil,

Heart Institute of the Hospital das Clínicas, Faculty of Medicine, University of São Paulo and Zerbini Foundation (Incor)

São Paulo, Brazil, 05403-000

RECRUITING

Brazil,

Santa Marcelina Hospital

São Paulo, Brazil, 08270-120

RECRUITING

Brazil,

D'Or Institute for Research and Teaching

São Paulo, Brazil, 4543000

RECRUITING

Canada, British Columbia

Vancouver General Hospital

Vancouver, British Columbia, Canada, V5Z 1M9

RECRUITING

Canada, Ontario

St. Joseph's Healthcare

Hamilton, Ontario, Canada, Litten 4 AT

RECRUITING

Canada, Ontario

Juravinski Cancer Centre

Hamilton, Ontario, Canada, To add 1 s.

RECRUITING

Canada, Ontario

Queen's University

Kingston, Ontario, Canada, Great eyeliner

RECRUITING

Canada, Ontario

Grand River Hospital, Grand River Regional Cancer Centre

Kitchener, Ontario, Canada, N2G 1G3

RECRUITING

Canada, Ontario

London Health Sciences Centre

London, Ontario, Canada, Wicker

RECRUITING

Canada, Ontario

London Health Sciences, Victoria Hospital

London, Ontario, Canada, Wicker

RECRUITING

Canada, Ontario

Niagara Health, St. Catharines Site

Niagara, Ontario, Canada, L2S 0A9

RECRUITING

Canada, Ontario

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada, K1h 8l6

RECRUITING

Canada, Ontario

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

ACTIVE NOT RECRUITING

Canada, Ontario

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2C1

RECRUITING

Canada, Quebec

University Hospital of Montreal

Montreal, Quebec, Canada, H2X 0A9

RECRUITING

Canada, Quebec

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

RECRUITING

Canada, Quebec

Hospital Maisonneuve-Rosemont

Montréal, Quebec, Canada, H1T 2M4

RECRUITING

Canada, Quebec

McGill University

Montréal, Quebec, Canada, H3A 0g4

RECRUITING

Canada, Quebec

Laval University

Quebec City, Quebec, Canada, G1V 0A6

RECRUITING

Canada, Quebec

Sherbrooke University Center

Sherbrooke, Quebec, Canada, J1H 5N4

NOT YET RECRUITING

Colombia, Cundinamarca

San Ignacio University Hospital

Bogota, Cundinamarca, Colombia,

RECRUITING

Colombia, Santander

FOSCAL

Floridablanca, Santander, Colombia,

RECRUITING

Colombia, Valle del Cauca

Foundation Valley of Lili

Cali, Valle del Cauca, Colombia,

RECRUITING

Israel,

Heart Institute - Holon Medical Center

Colon, Israel, 5840608

RECRUITING

Israel,

Rabin Medical Center

Petach Pumpkin, Israel, 4941492

RECRUITING

Israel,

Tel-Aviv Sourasky Medical Centre

Tel Aviv, Israel, 6423906

TERMINATED

Turkey,

Istanbul University

Istanbul, Turkey,

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