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

NCT03127631 | Recruiting DMC

• 1 other identifier: RADICALPC_009-001
• Study Type: interventional
• Target: 6,000
• Locations: 7 countries
• Sites: 54

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.

Conditions

Prostate Cancer; Cardiovascular Disease

Keywords

Androgen Deprivation Therapy

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.

  The primary efficacy outcome is the occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization.

  3-5 years

Secondary Outcomes (8)

• Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.

  3-5 years

• Secondary Efficacy Outcome - Composite of Death, MI, Stroke

  3-5 years

• Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.

  3-5 years

• Secondary Efficacy Outcome - Event Outcome - CV Death

  3-5 years

• Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction

  3-5 years

Other Outcomes (19)

• Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina

  3-5 years.

• Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation

  3-5 years

• Tertiary Efficacy Outcomes - Cognitive Function

  3-5 years

Study Arms (2)

Randomized - Intervention

ACTIVE COMPARATOR

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.

Behavioral: Nutrition; Behavioral: Exercise; Behavioral: Smoking cessation; Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin); Drug: ACE inhibitor

Randomized - Control

NO INTERVENTION

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.

Interventions

Nutrition BEHAVIORAL

Standardized advice on healthy diet practices.

Randomized - Intervention

Exercise BEHAVIORAL

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

Randomized - Intervention

Smoking cessation BEHAVIORAL

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

Randomized - Intervention

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

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.

Randomized - Intervention

ACE inhibitor DRUG

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 - Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Prostate Cancer Canada: collaborator
• Canadian Cancer Society (CCS): collaborator

Study Sites (54)

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Flinders Medical Center

Adelaide, South Australia, 5042, Australia

RECRUITING

Centro de Pesquisa Clínica do Brasil

Brasília, Federal District, 71625175, Brazil

RECRUITING

Hospital Felício Rocho

Belo Horizonte, Minas Gerais, 30110-934, Brazil

RECRUITING

Universidade Federal do Triângulo Mineiro

Uberaba, Minas Gerais, 38025-260, Brazil

RECRUITING

Sociedade Hospitalar Angelina Caron

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

RECRUITING

Nucleo de Pesquisa Clinica Hospital do Rocio

Campo Largo, Paraná, Brazil

RECRUITING

Centro Médico São Francisco

Curitiba, Paraná, 80810-050, Brazil

RECRUITING

Instituto De Medicina Integral Prof. Fernando Figueira - IMIP

Recife, Pernambuco, 50.070-902, Brazil

RECRUITING

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, 22240-006, Brazil

RECRUITING

Hospital de Caridade de Ijuí

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

RECRUITING

Hospital de Clínicas de Porto Alegre

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

RECRUITING

Irmandade Da Santa Casa De Misericórdia De Porto Alegre

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

RECRUITING

Hospital Mae de Deus

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

RECRUITING

Hospital Municipal de Barueri

Barueri, São Paulo, 06463-320, Brazil

RECRUITING

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

Botucatu, São Paulo, 18618-687, Brazil

RECRUITING

Hospital Universitário São Francisco na Providência de Deus

Bragança Paulista, São Paulo, 12.916-542, Brazil

RECRUITING

Fundacao Doutor Amaral Carvalho

Jaú, São Paulo, 17210080, Brazil

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto

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

RECRUITING

Santa Casa de São Paulo (IPITEC)

São Paulo, São Paulo, 01223-001, Brazil

RECRUITING

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, 01327001, Brazil

RECRUITING

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

São Paulo, São Paulo, 02189-000, Brazil

RECRUITING

Marina Leonardo

São Paulo, São Paulo, 04014-002, Brazil

RECRUITING

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

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Hospital Santa Marcelina

São Paulo, São Paulo, 08270-120, Brazil

RECRUITING

Instituto D'Or de Pesquisa e Ensino

São Paulo, São Paulo, 4543000, Brazil

RECRUITING

Integral Pesquisa e Ensino

Votuporanga, São Paulo, 15501-405, Brazil

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

St. Joseph's Healthcare

Hamilton, Ontario, L8N4A6, Canada

RECRUITING

Juravinski Cancer Centre

Hamilton, Ontario, L8V1C3, Canada

RECRUITING

Queen's University

Kingston, Ontario, K7L 3J7, Canada

RECRUITING

Grand River Hospital, Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

London Health Sciences, Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Niagara Health, St. Catharines Site

Niagara, Ontario, L2S 0A9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

ACTIVE NOT RECRUITING

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

University Hospital of Montreal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

McGill University

Montreal, Quebec, H3A 0G4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Laval University

Québec, Quebec, G1V 0A6, Canada

RECRUITING

Centre Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Hospital Universitario San Ignacio

Bogotá, Cundinamarca, Colombia

NOT YET RECRUITING

FOSCAL

Floridablanca, Santander Department, Colombia

RECRUITING

Fundacio Valle de Lili

Cali, Valle del Cauca Department, Colombia

RECRUITING

Heart Institute - Holon Medical Center

Holon, 5840608, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Tel-Aviv Sourasky Medical Centre

Tel Aviv, 6423906, Israel

RECRUITING

Istanbul University

Istanbul, Turkey (Türkiye)

TERMINATED

Related Publications (2)

• 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.

  PMID: 39407194 DERIVED

• 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.

  PMID: 34870071 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Cardiovascular Diseases

Interventions

Nutritional Status; Exercise; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Atorvastatin; Rosuvastatin Calcium; Pravastatin; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Protease Inhibitors

Study Officials

• Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC

  McMaster University

  STUDY DIRECTOR

Central Study Contacts

Sarah Karampatos, BASc, MSc

CONTACT

905-527-4322; sarah.karampatos@phri.ca

Steven Agapay, BSc

CONTACT

905-296-5764; steve.agapay@phri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: April 25, 2017
• Study Start: October 21, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3); BR (25); CA (17); CO (3); TU (1); US (2); AU (3)