Clinical trial NCT03127631: A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
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
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Cardiovascular Disease
Keywords: Androgen Deprivation Therapy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Canada
name: Canadian Cancer Society (CCS)
First posted: 2017-04-25
Enrollment: 6000
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
timeFrame: 3-5 years
Secondary outcomes:
measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
timeFrame: 3-5 years
measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke
timeFrame: 3-5 years
measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
timeFrame: 3-5 years
measure: Secondary Efficacy Outcome - Event Outcome - CV Death
timeFrame: 3-5 years
measure: Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
timeFrame: 3-5 years
measure: Secondary Efficacy Outcome - Event Outcome - Stroke
timeFrame: 3-5 years
measure: Secondary Efficacy Outcome - Event Outcome - Heart Failure
timeFrame: 3-5 years
measure: Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism
timeFrame: 3-5 years
Other outcomes:
measure: Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina
timeFrame: 3-5 years.
measure: Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Cognitive Function
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Physical Measurement - Grip Strength
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Physical Measurement - Timed Walk Test
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Physical Measurement - Walk Test
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Physical Frailty
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Physical Measurement - Waist
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - HbA1c
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Lipid Profile
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression
timeFrame: 3-5 years
measure: Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure
timeFrame: 3-5 years
measure: Safety Outcome - Emergent Adverse Event - Major Bleeding
timeFrame: 3-5 years
measure: Safety Outcome - Emergent Adverse Event - Myositis
timeFrame: 3-5 years
measure: Safety Outcome - Emergent Adverse Event - Liver Injury
timeFrame: 3-5 years
measure: Safety Outcome - Emergent Adverse Event - Kidney Injury
timeFrame: 3-5 years
Locations:
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Center
state: South Australia
city: Brasilia
country: Brazil
facility: Centro de Pesquisa Clínica do Brasil
state: DF
city: Belo Horizonte
country: Brazil
facility: Hospital Felício Rocho
state: Minas Gerais
city: Uberaba
country: Brazil
facility: Universidade Federal do Triângulo Mineiro
state: Minas Gerais
city: Campina Grande Do Sul
country: Brazil
facility: Sociedade Hospitalar Angelina Caron
state: Paraná
city: Campo Largo
country: Brazil
facility: Nucleo de Pesquisa Clinica Hospital do Rocio
state: Paraná
city: Curitiba
country: Brazil
facility: Centro Médico São Francisco
state: Paraná
city: Recife
country: Brazil
facility: Instituto De Medicina Integral Prof. Fernando Figueira - IMIP
state: Pernambuco
city: Ijuí
country: Brazil
facility: Hospital de Caridade de Ijuí
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade Da Santa Casa De Misericórdia De Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: Rio Grande Do Sul
city: Barueri
country: Brazil
facility: Hospital Municipal de Barueri
state: Sao Paulo
city: Botucatu
country: Brazil
facility: Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
state: São Paulo
city: Bragança Paulista
country: Brazil
facility: Hospital Universitário São Francisco na Providência de Deus
state: São Paulo
city: Jaú
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
state: São Paulo
city: São José Do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: São Paulo
city: Votuporanga
country: Brazil
facility: Integral Pesquisa e Ensino
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cardiologia
city: São Paulo
country: Brazil
facility: Santa Casa de São Paulo (IPITEC)
city: São Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro
city: São Paulo
country: Brazil
facility: Marina Leonardo
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor)
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
city: São Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital, Grand River Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences, Victoria Hospital
state: Ontario
city: Niagara
country: Canada
facility: Niagara Health, St. Catharines Site
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: University Hospital of Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: McGill University
state: Quebec
city: Quebec City
country: Canada
facility: Laval University
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Universitaire de Sherbrooke
state: Quebec
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio
state: Cundinamarca
city: Floridablanca
country: Colombia
facility: FOSCAL
state: Santander
city: Cali
country: Colombia
facility: Fundacio Valle de Lili
state: Valle del Cauca
city: Holon
country: Israel
facility: Heart Institute - Holon Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Centre
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: McMaster University
name: Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
role: STUDY_DIRECTOR
References:
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.