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

Primary Purpose

Prostate Cancer, Cardiovascular Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Nutrition
Exercise
Smoking cessation
Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
ACE inhibitor
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Androgen Deprivation Therapy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Georgia Cancer Center at Augusta UniversityRecruiting
  • University of Kansas Medical CenterRecruiting
  • Calvary Mater Newcastle
  • Westmead HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Flinders Medical CenterRecruiting
  • Centro de Pesquisa Clínica do BrasilRecruiting
  • Hospital Felício RochoRecruiting
  • Universidade Federal do Triângulo MineiroRecruiting
  • Sociedade Hospitalar Angelina CaronRecruiting
  • Nucleo de Pesquisa Clinica Hospital do RocioRecruiting
  • Centro Médico São FranciscoRecruiting
  • Instituto De Medicina Integral Prof. Fernando Figueira - IMIPRecruiting
  • Hospital de Caridade de IjuíRecruiting
  • Hospital de Clínicas de Porto AlegreRecruiting
  • Irmandade Da Santa Casa De Misericórdia De Porto AlegreRecruiting
  • Hospital Mae de DeusRecruiting
  • Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESPRecruiting
  • Hospital Universitário São Francisco na Providência de DeusRecruiting
  • Fundacao Doutor Amaral CarvalhoRecruiting
  • Fundação Faculdade Regional de Medicina de São José do Rio PretoRecruiting
  • Integral Pesquisa e EnsinoRecruiting
  • Instituto Nacional de Cardiologia
  • Santa Casa de São Paulo (IPITEC)Recruiting
  • Hospital Alemao Oswaldo CruzRecruiting
  • Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-BrasileiroRecruiting
  • Marina LeonardoRecruiting
  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor)Recruiting
  • Hospital Santa MarcelinaRecruiting
  • Instituto D'Or de Pesquisa e EnsinoRecruiting
  • Vancouver General Hospital
  • St. Joseph's HealthcareRecruiting
  • Juravinski Cancer CentreRecruiting
  • Queen's UniversityRecruiting
  • Grand River Hospital, Grand River Regional Cancer CentreRecruiting
  • London Health Sciences CentreRecruiting
  • London Health Sciences, Victoria HospitalRecruiting
  • Niagara Health, St. Catharines SiteRecruiting
  • Ottawa Hospital Research InstituteRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • University Health Network, Princess Margaret Cancer Centre
  • University Hospital of MontrealRecruiting
  • Jewish General HospitalRecruiting
  • Hopital Maisonneuve-RosemontRecruiting
  • McGill UniversityRecruiting
  • Laval UniversityRecruiting
  • Centre Universitaire de SherbrookeRecruiting
  • Hospital Universitario San Ignacio
  • FOSCALRecruiting
  • Fundacio Valle de LiliRecruiting
  • Heart Institute - Holon Medical CenterRecruiting
  • Rabin Medical CenterRecruiting
  • Tel-Aviv Sourasky Medical CentreRecruiting
  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Randomized - Intervention

Randomized - Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
The occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure.
Secondary Efficacy Outcome - Composite of Death, MI, Stroke
The composite of cardiovascular death, myocardial infarction, or stroke.
Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
The composite of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina.
Secondary Efficacy Outcome - Event Outcome - CV Death
Cardiovascular death.
Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
Myocardial infarction.
Secondary Efficacy Outcome - Event Outcome - Stroke
Stroke.
Secondary Efficacy Outcome - Event Outcome - Heart Failure
Heart failure.
Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism
Venous Thromboembolism.

Full Information

First Posted
September 7, 2016
Last Updated
September 18, 2023
Sponsor
McMaster University
Collaborators
Prostate Cancer Canada, Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT03127631
Brief Title
A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
Acronym
RADICALPC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2015 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Prostate Cancer Canada, Canadian Cancer Society (CCS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Cardiovascular Disease
Keywords
Androgen Deprivation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomized - Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Randomized - Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition
Intervention Description
Standardized advice on healthy diet practices.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Standardized advice on exercise including strength training and resistance training exercises.
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation
Intervention Description
Advice to quit smoking, if applicable, and on available aids to quit smoking,
Intervention Type
Drug
Intervention Name(s)
Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ACE inhibitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
Description
The primary efficacy outcome is the occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization.
Time Frame
3-5 years
Secondary Outcome Measure Information:
Title
Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
Description
The occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure.
Time Frame
3-5 years
Title
Secondary Efficacy Outcome - Composite of Death, MI, Stroke
Description
The composite of cardiovascular death, myocardial infarction, or stroke.
Time Frame
3-5 years
Title
Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
Description
The composite of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina.
Time Frame
3-5 years
Title
Secondary Efficacy Outcome - Event Outcome - CV Death
Description
Cardiovascular death.
Time Frame
3-5 years
Title
Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
Description
Myocardial infarction.
Time Frame
3-5 years
Title
Secondary Efficacy Outcome - Event Outcome - Stroke
Description
Stroke.
Time Frame
3-5 years
Title
Secondary Efficacy Outcome - Event Outcome - Heart Failure
Description
Heart failure.
Time Frame
3-5 years
Title
Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism
Description
Venous Thromboembolism.
Time Frame
3-5 years
Other Pre-specified Outcome Measures:
Title
Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina
Description
New or worsening angina.
Time Frame
3-5 years.
Title
Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation
Description
New atrial fibrillation.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Cognitive Function
Description
Cognitive function, as measured by the DSS test.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Physical Measurement - Grip Strength
Description
Handgrip strength, as measured using the JAMAR Dynamometer.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Physical Measurement - Timed Walk Test
Description
Timed-get-up-and-go-test.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Physical Measurement - Walk Test
Description
Six-minute walk distance.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Physical Frailty
Description
Physical Frailty
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Physical Measurement - Waist
Description
Waist circumference.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - HbA1c
Description
HbA1c concentration.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Lipid Profile
Description
Lipid profile.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death
Description
Prostate cancer death.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression
Description
Distant prostate cancer progression.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC
Description
Development of castrate-resistant prostate cancer
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression
Description
PSA progression.
Time Frame
3-5 years
Title
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure
Description
Biochemical failure.
Time Frame
3-5 years
Title
Safety Outcome - Emergent Adverse Event - Major Bleeding
Description
Major bleeding.
Time Frame
3-5 years
Title
Safety Outcome - Emergent Adverse Event - Myositis
Description
Myositis.
Time Frame
3-5 years
Title
Safety Outcome - Emergent Adverse Event - Liver Injury
Description
Liver injury.
Time Frame
3-5 years
Title
Safety Outcome - Emergent Adverse Event - Kidney Injury
Description
Kidney injury.
Time Frame
3-5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Karampatos, BASc, MSc
Phone
905-527-4322
Ext
40506
Email
sarah.karampatos@phri.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Agapay, BSc
Phone
905-296-5764
Email
steve.agapay@phri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
Organizational Affiliation
McMaster University
Official's Role
Study Director
Facility Information:
Facility Name
Georgia Cancer Center at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priyanshu Nain
Email
PNAIN@augusta.edu
First Name & Middle Initial & Last Name & Degree
Avirup Guha
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Christenson
Email
tchristenson3@kumc.edu
First Name & Middle Initial & Last Name & Degree
Charles Porter
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Sverdlov
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sindhu Mohanty
Phone
+61 2 8890 8238
Email
Sindhu.Mohanty@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Tania Moujaber
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Appleton
Email
Ryan.Appleton@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Agnes Lagula
Email
Agnes.Lagula@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Braden Higgs
Facility Name
Flinders Medical Center
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonia Bromley
Email
tonia.bromley@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Joseph Selvanayagam
Facility Name
Centro de Pesquisa Clínica do Brasil
City
Brasilia
State/Province
DF
ZIP/Postal Code
71625175
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Araujo
Email
monitor2@metabolismo.com.br
First Name & Middle Initial & Last Name & Degree
joao Borges
Facility Name
Hospital Felício Rocho
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-934
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais Ribeiro
Email
thaispesquisaclinica@gmail.com
First Name & Middle Initial & Last Name & Degree
Livia Pereira
Facility Name
Universidade Federal do Triângulo Mineiro
City
Uberaba
State/Province
Minas Gerais
ZIP/Postal Code
38025-260
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline Carlos
Email
alinemenezescarlos@gmail.com
First Name & Middle Initial & Last Name & Degree
Livia Oliveira
Facility Name
Sociedade Hospitalar Angelina Caron
City
Campina Grande Do Sul
State/Province
Paraná
ZIP/Postal Code
83.430-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maynara Martins
Email
may.schuh@gmail.com
First Name & Middle Initial & Last Name & Degree
Carlos Nakashima
Facility Name
Nucleo de Pesquisa Clinica Hospital do Rocio
City
Campo Largo
State/Province
Paraná
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielly Lech
Email
gabriellyclech@gmail.com
First Name & Middle Initial & Last Name & Degree
Cesar Dusilek
Facility Name
Centro Médico São Francisco
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80810-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Rochitti
Email
rochitti.car@gmail.com
First Name & Middle Initial & Last Name & Degree
Gustavo Marques
Facility Name
Instituto De Medicina Integral Prof. Fernando Figueira - IMIP
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50.070-902
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalia da Silva
Email
nathalia.santos@imip.org.br
First Name & Middle Initial & Last Name & Degree
Jurema Lima
Facility Name
Hospital de Caridade de Ijuí
City
Ijuí
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Uggeri
Email
enfermeira.nep@hci.org.br
First Name & Middle Initial & Last Name & Degree
Rafaela Piccoli
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Silveira
Email
apbsilveira@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Felipe Valle
Facility Name
Irmandade Da Santa Casa De Misericórdia De Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Indianara Porgere
Email
indianara.porgere@santacasa.org.br
First Name & Middle Initial & Last Name & Degree
Katsuki Tiscoski
Facility Name
Hospital Mae de Deus
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90840-440
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Crestani
Email
assistencial5_hmd@centrodepesquisaclinica.com.br
First Name & Middle Initial & Last Name & Degree
Eduardo Schlabendorff
Facility Name
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-687
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelmara Camargo
Email
nelmara.camargo@unesp.br
First Name & Middle Initial & Last Name & Degree
Aline Fantinati
Email
aline.witaicenis@unesp.br
First Name & Middle Initial & Last Name & Degree
Mayra Frankenfeld
Facility Name
Hospital Universitário São Francisco na Providência de Deus
City
Bragança Paulista
State/Province
São Paulo
ZIP/Postal Code
12.916-542
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela de Queiroz
Email
gabrielaq.cepec@gmail.com
First Name & Middle Initial & Last Name & Degree
Murillo Antunes
Facility Name
Fundacao Doutor Amaral Carvalho
City
Jaú
State/Province
São Paulo
ZIP/Postal Code
17210080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Coutinho
Email
centrodepesquisas.adriana@amaralcarvalho.org.br
First Name & Middle Initial & Last Name & Degree
Debora Campos
Email
centrodepesquisas.debora@amaralcarvalho.org.br
First Name & Middle Initial & Last Name & Degree
Patricia Beato
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José Do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Lacava De Aquino
Email
barbarahb.cip@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniel Araujo
Facility Name
Integral Pesquisa e Ensino
City
Votuporanga
State/Province
São Paulo
ZIP/Postal Code
15501-405
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Morelli
Email
coordena2.integral@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mauro Hernandes
Facility Name
Instituto Nacional de Cardiologia
City
Rio De Janeiro
ZIP/Postal Code
22240-006
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Santa Casa de São Paulo (IPITEC)
City
São Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela de Santana
Email
daniela.pesquisascsp@gmail.com
First Name & Middle Initial & Last Name & Degree
Luis Eduardo Silva Moz
Facility Name
Hospital Alemao Oswaldo Cruz
City
São Paulo
ZIP/Postal Code
01327001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonia Rodrigues
Email
antonia.rodrigues@haoc.com.br
First Name & Middle Initial & Last Name & Degree
Ariel Kann
Facility Name
Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro
City
São Paulo
ZIP/Postal Code
02189-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valquiria Ritter
Email
valquiria.ritter@hnipo.org.br
First Name & Middle Initial & Last Name & Degree
Maristela Miranda
Facility Name
Marina Leonardo
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Leonardo
Email
marina.leonardo@hospitalsaocamilosp.org.br
First Name & Middle Initial & Last Name & Degree
Ivanize Alves
Email
ivanize.alves@hospitalsaocamilosp.org.br
First Name & Middle Initial & Last Name & Degree
Cristiano Freitas Souza
Facility Name
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor)
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Nascimento
Email
beatriz.nascimento@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Ludhmila Hajjar
Facility Name
Hospital Santa Marcelina
City
São Paulo
ZIP/Postal Code
08270-120
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila Caroline
Email
camilacpc@santamarcelina.org
First Name & Middle Initial & Last Name & Degree
Denise Da Silva
Email
denisecpc@santamarcelina.org
First Name & Middle Initial & Last Name & Degree
Roberto Odebrecht Rocha
Facility Name
Instituto D'Or de Pesquisa e Ensino
City
São Paulo
ZIP/Postal Code
4543000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcio Ferraz
Email
marcio.ferraz@idor.org
First Name & Middle Initial & Last Name & Degree
Jose Mauricio Mota
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Mirshahi
Email
mirshahi@HHSC.CA
First Name & Middle Initial & Last Name & Degree
Dr. Bobby Shayegan, MD,FRCSC
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shauna Szendrey
Email
szendreys@hhsc.ca
First Name & Middle Initial & Last Name & Degree
Dr. Jehonathan Pinthus, MD,FRCS(C),PhD
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Affaan Mahmud
Email
affaanmahmud@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Robert Siemens, MD,FRCSC
Facility Name
Grand River Hospital, Grand River Regional Cancer Centre
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie O'Brien
Email
Stephanie.O'Brien@grhosp.on.ca
First Name & Middle Initial & Last Name & Degree
Darin Gopaul, MD
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cadence Baker
Email
Cadence.Baker@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Dr. Patrick Luke, MD,FRCSC
Facility Name
London Health Sciences, Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nidhi Shah
Email
Nidhi.Shah@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Joseph Chin, MD, FRCSC
Facility Name
Niagara Health, St. Catharines Site
City
Niagara
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vaibhav Chudasama
Email
chudasamav@HHSC.CA
First Name & Middle Initial & Last Name & Degree
Ian Brown, BSc, MD, FRCPC
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Yachnin, ND, MSc
Email
dyachnin@toh.ca
First Name & Middle Initial & Last Name & Degree
Dr. Luke Lavallee, MDCM,MSc,FRCSC
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlene Kebabdjian
Email
marlene.kebabdjian@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Dr. Laurence Klotz, MD,FRCS(C)
Facility Name
University Health Network, Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
University Hospital of Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imene Chergui
Email
imene.chergui.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Dr. Emmanuelle Duceppe, MD,FRCPC
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelli Dimayuga
Phone
514 340 8222
Ext
21285
Email
Kelli.Dimayuga.ccomtl@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Dr. Tamim Niazi, MDCM
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anabel Grullon
Email
anabel.grullon.cemtl@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Nawar Hanna, MD, MSc
Facility Name
McGill University
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 0G4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bersabeh Hailemariam
Email
bahmb04@gmail.com
First Name & Middle Initial & Last Name & Degree
Negareh Mousavi, MD
Facility Name
Laval University
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Larouche
Phone
418 525 4444
Ext
13248
Email
audrey.larouche@crchudequebec.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Dr. Vincent Fradet, MD,PhD,FRCSC
Facility Name
Centre Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsie Morneau
Email
elsie.morneau.ciussse-chus@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Robert Sabbagh, MSc, MD, FRCSC
Facility Name
Hospital Universitario San Ignacio
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Enrique Cita
Facility Name
FOSCAL
City
Floridablanca
State/Province
Santander
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Maria Ramos Franco
Email
ana.ramos@foscal.com.co
First Name & Middle Initial & Last Name & Degree
Nicolas Villareal
Facility Name
Fundacio Valle de Lili
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brayan Daniel Cordoba Melo
Email
brayan.cordoba.me@fvl.org.co
First Name & Middle Initial & Last Name & Degree
Juan Esteban Gomez Mesa
Facility Name
Heart Institute - Holon Medical Center
City
Holon
ZIP/Postal Code
5840608
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Michael
Phone
972 (3)7471200
Email
annasa3@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Elena Agronov Kaif
Email
elenaag@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Zaza Iakobishvili
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natali Oginets
Email
nataliog@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Alon Eisen
Facility Name
Tel-Aviv Sourasky Medical Centre
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Liberzon
Email
marinali@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Limor Ben Zvi
Email
limorb@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
David Sarid
Facility Name
Istanbul University
City
Istanbul
Country
Turkey
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34870071
Citation
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.
Results Reference
derived

Learn more about this trial

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

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