A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
NCT ID: NCT03127631
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6000 participants
INTERVENTIONAL
2015-10-21
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Randomized - Intervention
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.
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.
Randomized - Control
The control will consist of usual clinical care, which may include a referral to a cardiologist or internist, or the use of treatments included in the intervention as clinically indicated, if part of the treating physician's standard practice.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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. 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
45 Years
MALE
No
Sponsors
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Prostate Cancer Canada
OTHER
Canadian Cancer Society (CCS)
OTHER
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
Role: STUDY_DIRECTOR
McMaster University
Locations
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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)
Countries
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Central Contacts
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Facility Contacts
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References
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Dahan J, Pinthus J, Delouya G, Taussky D, Duceppe E, de Jesus A, Leong D. Investigation of association between clinically significant prostate cancer, obesity and platelet to-lymphocyte ratio and neutrophil -to-lymphocyte ratio. BMC Urol. 2024 Oct 16;24(1):226. doi: 10.1186/s12894-024-01617-2.
Savija N, Leong DP, Pinthus J, Karampatos S, Shayegan B, Mian R, Rangarajan S, Fradet V, de Souza RJ, Mente A, Dehghan M. Development and Comparability of a Short Food-Frequency Questionnaire to Assess Diet in Prostate Cancer Patients: The Role of Androgen Deprivation Therapy in CArdiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC) Substudy. Curr Dev Nutr. 2021 Aug 12;5(11):nzab106. doi: 10.1093/cdn/nzab106. eCollection 2021 Nov.
Other Identifiers
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RADICALPC_009-001
Identifier Type: -
Identifier Source: org_study_id
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