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Prostate CancerRADICALPCNCT03127631

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

A study testing Nutrition, Exercise and Smoking cessation in people with Prostate Cancer and Cardiovascular Disease, run by McMaster University at 61 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Prostate Cancer, Cardiovascular Disease
What is being tested?
Nutrition, Exercise and Smoking cessation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
61 sitesin 9 countries
Study dates
21 Oct 2015to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

61 sites in 9 countries.

61 sites in 9 countries

Brazil25 sites
  • Hospital Municipal de Barueri

    Barueri, São Paulo, 06463-320

  • Hospital Felício Rocho

    Belo Horizonte, Minas Gerais, 30110-934

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

    Botucatu, São Paulo, 18618-687

  • Hospital Universitário São Francisco na Providência de Deus

    Bragança Paulista, São Paulo, 12.916-542

  • Centro de Pesquisa Clínica do Brasil

    Brasília, Federal District, 71625175

  • Sociedade Hospitalar Angelina Caron

    Campina Grande do Sul, Paraná, 83.430-000

  • Nucleo de Pesquisa Clinica Hospital do Rocio

    Campo Largo, Paraná

  • Centro Médico São Francisco

    Curitiba, Paraná, 80810-050

  • Hospital de Caridade de Ijuí

    Ijuí, Rio Grande do Sul, 98700-000

  • Fundacao Doutor Amaral Carvalho

    Jaú, São Paulo, 17210080

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Irmandade Da Santa Casa De Misericórdia De Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90840-440

  • Instituto De Medicina Integral Prof. Fernando Figueira - IMIP

    Recife, Pernambuco, 50.070-902

  • Instituto Nacional de Cardiologia

    Rio de Janeiro, Rio de Janeiro, 22240-006

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

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

  • Santa Casa de São Paulo (IPITEC)

    São Paulo, São Paulo, 01223-001

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01327001

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

    São Paulo, São Paulo, 02189-000

  • Núcleo de Pesquisa e Ensino da Rede São Camilo

    São Paulo, São Paulo, 04014-002

  • 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

  • Hospital Santa Marcelina

    São Paulo, São Paulo, 08270-120

  • Instituto D'Or de Pesquisa e Ensino

    São Paulo, São Paulo, 4543000

  • Universidade Federal do Triângulo Mineiro

    Uberaba, Minas Gerais, 38025-260

  • Integral Pesquisa e Ensino

    Votuporanga, São Paulo, 15501-405

Other trials in Brazil

Canada17 sites
  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N4A6

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V1C3

  • Queen's University

    Kingston, Ontario, K7L 3J7

  • Grand River Hospital, Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • London Health Sciences, Victoria Hospital

    London, Ontario, N6A 5W9

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • University Hospital of Montreal

    Montreal, Quebec, H2X 0A9

  • McGill University

    Montreal, Quebec, H3A 0G4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Niagara Health, St. Catharines Site

    Niagara, Ontario, L2S 0A9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Laval University

    Québec, Quebec, G1V 0A6

  • Centre Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

United States4 sites
  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

India4 sites
  • St. John's Medical College and Hospital

    Bangalore, Karntaka, 560034

  • Sri shanakara cancer Hospital and Research Centre

    Bengaluru, Kamataka, 560004

  • Kamineni Academy of Medical Sciences and Research Centre

    Hyderabad, Telangana, 500068

  • Sri Ram Cancer & Superspeciality Centre, Mahatma Gandhi Hospital

    Sītāpura, Jaipur, 302022

Other trials in India

Australia3 sites
  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Center

    Adelaide, South Australia, 5042

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Colombia3 sites
  • Hospital Universitario San Ignacio

    Bogotá, Cundinamarca

  • Fundacio Valle de Lili

    Cali, Valle del Cauca Department

  • FOSCAL

    Floridablanca, Santander Department

Other trials in Colombia

Israel3 sites
  • Heart Institute - Holon Medical Center

    Holon, 5840608

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Tel-Aviv Sourasky Medical Centre

    Tel Aviv, 6423906

Other trials in Israel

Singapore1 site
  • National University Hospital

    Singapore, Singapore, 119228

Other trials in Singapore

Turkey (Türkiye)1 site
  • Istanbul University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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)

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.

Read the 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.

Being tested
Nutrition, Exercise, Smoking cessation, Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin), ACE inhibitor
Keywords
Androgen Deprivation Therapy
Medical subject headings
Prostatic Neoplasms, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NutritionBehavioural

    Standardized advice on healthy diet practices.

  • ExerciseBehavioural

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

  • Smoking cessationBehavioural

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

  • 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.

  • ACE inhibitorDrug

    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.

Study groups in NCT03127631
Study groupRoleWhat they receive
Randomized - InterventionActive comparatorThe 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.
Receives: Behavioral: Nutrition; Behavioral: Exercise; Behavioral: Smoking cessation; Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin); Drug: ACE inhibitor
Randomized - ControlNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 3-5 years

  2. 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.

    Measured: 3-5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start21 Oct 2015
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127631
Sponsor's protocol ID
RADICALPC_009-001
Acronym
RADICALPC
Status last verified
Jun 2026
First submitted
7 Sep 2016
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Leong DP, Higano C, Cano Garcia C, Fradet V, Siemens DR, Niazi T, Shayegan B, Guha A, Cirne F, Selvanayagam JB, Violette PD, Valle FH, Lavallee LT, Duceppe E, Anderson P, Xavier D, Lopez-Lopez JP, Villareal Trujillo N, Galapo Kann A, Piccoli RK, Mourtzakis M, Sarid D, Narasimha S, Luke PPW, Hajjar LA, Lukka H, Klotz L, Balasubramanian K, Mian R, Agapay S, Rangarajan S, Karampatos S, Ng KKH, Avezum A, Devereaux PJ, Pinthus JH; RADICAL PC Investigators. Specialist Referral for Cardiovascular Risk in Patients With Prostate Cancer: A Randomized Clinical Trial. JAMA Intern Med. 2026 Aug 30. doi: 10.1001/jamainternmed.2026.4773. Online ahead of print.

    PubMed 42669035
  • 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.

    PubMed 39407194
  • 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.

    PubMed 34870071

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition, Exercise and Smoking cessation in people with Prostate Cancer and Cardiovascular Disease, run by McMaster University at 61 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Brazil, Canada, United States, India, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: 3-5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03127631, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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