A Study for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICALPC)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Disease; Prostate Cancer
• Intervention / Treatment: Behavioral: Nutrition; Behavioral: Exercise; Behavioral: Smoking cessation; Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin); Drug: ACE inhibitor

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
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Adelaide, South Australia, Australia, 5042
      • Flinders Medical Center
• Brazil
  • Federal District
    • Brasília, Federal District, Brazil, 71625175
      • Centro de Pesquisa Clínica do Brasil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30110-934
      • Hospital Felício Rocho
    • Uberaba, Minas Gerais, Brazil, 38025-260
      • Universidade Federal do Triângulo Mineiro
  • Paraná
    • Campina Grande do Sul, Paraná, Brazil, 83.430-000
      • Sociedade Hospitalar Angelina Caron
    • Campo Largo, Paraná, Brazil
      • Nucleo de Pesquisa Clinica Hospital do Rocio
    • Curitiba, Paraná, Brazil, 80810-050
      • Centro Médico São Francisco
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50.070-902
      • Instituto De Medicina Integral Prof. Fernando Figueira - IMIP
  • Rio Grande do Sul
    • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • Hospital de Caridade de Ijuí
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Irmandade Da Santa Casa De Misericórdia De Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90840-440
      • Hospital Mae de Deus
  • Rio de Janeiro
    • Rio de Janeiro, Rio de Janeiro, Brazil, 22240-006
      • Instituto Nacional de Cardiologia
  • São Paulo
    • Barueri, São Paulo, Brazil, 06463-320
      • Hospital Municipal de Barueri
    • Botucatu, São Paulo, Brazil, 18618-687
      • Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
    • Bragança Paulista, São Paulo, Brazil, 12.916-542
      • Hospital Universitário São Francisco na Providência de Deus
    • Jaú, São Paulo, Brazil, 17210080
      • Fundacao Doutor Amaral Carvalho
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto
    • São Paulo, São Paulo, Brazil, 01223-001
      • Santa Casa de São Paulo (IPITEC)
    • São Paulo, São Paulo, Brazil, 01327001
      • Hospital Alemao Oswaldo Cruz
    • São Paulo, São Paulo, Brazil, 02189-000
      • Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro
    • São Paulo, São Paulo, Brazil, 05403-000
      • 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, 08270-120
      • Hospital Santa Marcelina
    • São Paulo, São Paulo, Brazil, 4543000
      • Instituto D'Or de Pesquisa e Ensino
    • São Paulo, São Paulo, Brazil, 04014-002
      • Núcleo de Pesquisa e Ensino da Rede São Camilo
    • Votuporanga, São Paulo, Brazil, 15501-405
      • Integral Pesquisa e Ensino
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • St. Joseph's Healthcare
    • Hamilton, Ontario, Canada, L8V1C3
      • Juravinski Cancer Centre
    • Kingston, Ontario, Canada, K7L 3J7
      • Queen's University
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Hospital, Grand River Regional Cancer Centre
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences, Victoria Hospital
    • Niagara, Ontario, Canada, L2S 0A9
      • Niagara Health, St. Catharines Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2C1
      • University Health Network, Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont
    • Montreal, Quebec, Canada, H3A 0G4
      • McGill University
    • Montreal, Quebec, Canada, H2X 0A9
      • University Hospital of Montreal
    • Québec, Quebec, Canada, G1V 0A6
      • Laval University
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Universitaire de Sherbrooke
• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia
      • Hospital Universitario San Ignacio
  • Santander Department
    • Floridablanca, Santander Department, Colombia
      • FOSCAL
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia
      • Fundacio Valle de Lili
• India
  • Jaipur
    • Sītāpura, Jaipur, India, 302022
      • Sri Ram Cancer & Superspeciality Centre, Mahatma Gandhi Hospital
  • Kamataka
    • Bengaluru, Kamataka, India, 560004
      • Sri shanakara cancer Hospital and Research Centre
  • Karntaka
    • Bangalore, Karntaka, India, 560034
      • St. John's Medical College and Hospital
  • Telangana
    • Hyderabad, Telangana, India, 500068
      • Kamineni Academy of Medical Sciences and Research Centre
• Israel
  • Holon, Israel, 5840608
    • Heart Institute - Holon Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel-Aviv Sourasky Medical Centre
• Singapore
  • Singapore
    • Singapore, Singapore, Singapore, 119228
      • National University Hospital
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul University
• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Cancer Center at Augusta University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Nutrition; Standardized advice on healthy diet practices.; Behavioral: Exercise; Standardized advice on exercise including strength training and resistance training exercises.; Behavioral: Smoking cessation; Advice to quit smoking, if applicable, and on available aids to quit smoking,; Drug: 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.; Drug: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hierarchical composite of cardiovascular death, myocardial infarction, stroke, heart failure, cholesterol control (defined as total cholesterol ≤4mmol/L) and systolic blood pressure control (defined as systolic blood pressure ≤130mmHg).	Hierarchical composite of cardiovascular death, myocardial infarction, stroke, heart failure, cholesterol control (defined as total cholesterol ≤4mmol/L) and systolic blood pressure control (defined as systolic blood pressure ≤130mmHg).	3-5 years
Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.	Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.	3-5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint - Time to the first occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure	The time to the first occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure	3-5 years
Secondary Endpoint - Time to first occurrence of cardiovascular death, myocardial infarction, or stroke	The time to first occurrence of cardiovascular death, myocardial infarction, or stroke	3-5 years
Secondary Endpoint - Time to first occurrence of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina,	The time to first occurrence of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina,	3-5 years
Secondary Endpoint - Time to cardiovascular death	Time to cardiovascular death	3-5 years
Secondary Endpoint - Time to myocardial infarction	Time to myocardial infarction	3-5 years
Secondary Endpoint - Time to stroke	Time to stroke	3-5 years
Secondary Endpoint - Time to heart failure	Time to heart failure	3-5 years
Secondary Endpoint - Time to venous thromboembolism	Time to venous thromboembolism	3-5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome - Emergent Adverse Event - Major Bleeding	Major bleeding.	3-5 years
Safety Outcome - Emergent Adverse Event - Myositis	Myositis.	3-5 years
Safety Outcome - Emergent Adverse Event - Liver Injury	Liver injury.	3-5 years
Safety Outcome - Emergent Adverse Event - Kidney Injury	Kidney injury.	3-5 years
Exploratory Analyses Endpoint - Systolic Blood Pressure	Measure of systolic blood pressure	3-5 years
Exploratory Analyses Endpoint - Total and Low-Density Lipoprotein Cholesterol	Measure of total and low-density lipoprotein cholesterol	3-5 years
Exploratory Analyses Endpoint - Hemoglobin A1c Concentration	Hemoglobin A1c concentration	3-5 years
Exploratory Analyses Endpoint - Handgrip Strength	Measure of handgrip strength	3-5 years
Exploratory Analyses Endpoint - Get-Up-and-Go Time	Timed get-up-and-go test	3-5 years
Exploratory Analyses Endpoint - Waist Circumference	Measure of waist circumference	3-5 years
Exploratory Analyses Endpoint - Six-Minute Walk Distance	Distance walked in six minutes	3-5 years
Exploratory Analyses Endpoint - Digital Symbol Substitution (DSS) Test	Digital symbol substitution (DSS) test score	3-5 years

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Cancer Society (CCS); Tolmar Inc.; Prostate Cancer Canada
• Investigators: Study Director: Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC, McMaster University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Androgen Deprivation Therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Cardiovascular Diseases; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Hydrocarbons; Hydrocarbons, Cyclic; Diet, Food, and Nutrition; Physiological Phenomena; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Amides; Nutritional Physiological Phenomena; Pyrimidines; Population Characteristics; Hydrocarbons, Halogenated; Health Status; Demography; Pyrroles; Heptanoic Acids; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Lovastatin; Atorvastatin; Rosuvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin; Angiotensin-Converting Enzyme Inhibitors; Pravastatin; Exercise; Nutritional Status
• Other Study ID Numbers: RADICALPC_009-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No