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

January 29, 2025 updated by: McMaster University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
    • South Australia
      • Adelaide, South Australia, Australia, 5000
      • Adelaide, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Center
        • Contact:
        • Contact:
          • Joseph Selvanayagam
  • Brazil
      • Rio De Janeiro, Brazil, 22240-006
        • Recruiting
        • Instituto Nacional de Cardiologia
        • Contact:
        • Contact:
          • Aurora Issa
      • São Paulo, Brazil, 01327001
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor)
        • Contact:
        • Contact:
          • Ludhmila Hajjar
      • São Paulo, Brazil, 08270-120
      • São Paulo, Brazil, 01223-001
      • São Paulo, Brazil, 02189-000
        • Recruiting
        • Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro
        • Contact:
        • Contact:
          • Maristela Miranda
      • São Paulo, Brazil, 04014-002
      • São Paulo, Brazil, 4543000
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino
        • Contact:
        • Contact:
          • Jose Mauricio Mota
    • DF
      • Brasilia, DF, Brazil, 71625175
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-934
      • Uberaba, Minas Gerais, Brazil, 38025-260
    • Paraná
      • Campina Grande Do Sul, Paraná, Brazil, 83.430-000
        • Recruiting
        • Sociedade Hospitalar Angelina Caron
        • Contact:
        • Contact:
          • Carlos Nakashima
      • Campo Largo, Paraná, Brazil
        • Recruiting
        • Nucleo de Pesquisa Clinica Hospital do Rocio
        • Contact:
        • Contact:
          • Cesar Dusilek
      • Curitiba, Paraná, Brazil, 80810-050
        • Recruiting
        • Centro Médico São Francisco
        • Contact:
        • Contact:
          • Gustavo Marques
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50.070-902
        • Recruiting
        • Instituto de Medicina Integral Prof. Fernando Figueira - Imip
        • Contact:
        • Contact:
          • Jurema Lima
    • Rio Grande Do Sul
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Contact:
          • Felipe Valle
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
    • Sao Paulo
      • Barueri, Sao Paulo, Brazil, 06463-320
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-687
        • Recruiting
        • Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
        • Contact:
        • Contact:
        • Contact:
          • Mayra Frankenfeld
      • Bragança Paulista, São Paulo, Brazil, 12.916-542
        • Recruiting
        • Hospital Universitário São Francisco na Providência de Deus
        • Contact:
          • Murillo Antunes
        • Contact:
      • Jaú, São Paulo, Brazil, 17210080
      • São José Do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
        • Contact:
        • Contact:
          • Camila Ferrari
      • Votuporanga, São Paulo, Brazil, 15501-405
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
        • Contact:
          • Margot Davis, MD SM FRCPC
    • Ontario
      • Hamilton, Ontario, Canada, L8N4A6
        • Recruiting
        • St. Joseph's Healthcare
        • Contact:
        • Contact:
          • Dr. Bobby Shayegan, MD,FRCSC
      • Hamilton, Ontario, Canada, L8V1C3
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:
        • Contact:
        • Contact:
          • Dr. Jehonathan Pinthus, MD,FRCS(C),PhD
      • Kingston, Ontario, Canada, K7L 3J7
      • Kitchener, Ontario, Canada, N2G 1G3
        • Recruiting
        • Grand River Hospital, Grand River Regional Cancer Centre
        • Contact:
        • Contact:
          • Darin Gopaul, MD
      • London, Ontario, Canada, N6A 5W9
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences, Victoria Hospital
        • Contact:
        • Contact:
          • Melissa Huynh, B.Sc. (Hons), MD, FRCSC
      • Niagara, Ontario, Canada, L2S 0A9
        • Recruiting
        • Niagara Health, St. Catharines Site
        • Contact:
        • Contact:
          • Patrick Anderson
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
        • Contact:
          • Dr. Luke Lavallee, MDCM,MSc,FRCSC
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Contact:
          • Dr. Laurence Klotz, MD,FRCS(C)
      • Toronto, Ontario, Canada, M5G 2C1
        • Active, not recruiting
        • University Health Network, Princess Margaret Cancer Centre
    • Quebec
  • Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
        • Not yet recruiting
        • Hospital Universitario San Ignacio
        • Contact:
        • Contact:
        • Contact:
          • Jose Enrique Cita
    • Santander
    • Valle del Cauca
      • Cali, Valle del Cauca, Colombia
        • Recruiting
        • Fundacio Valle de Lili
        • Contact:
        • Contact:
          • Juan Esteban Gomez Mesa
  • Israel
      • Holon, Israel, 5840608
        • Recruiting
        • Heart Institute - Holon Medical Center
        • Contact:
        • Contact:
        • Contact:
          • Zaza Iakobishvili
      • Petach Tikva, Israel, 4941492
      • Tel Aviv, Israel, 6423906
  • Turkey
      • Istanbul, Turkey
        • Terminated
        • Istanbul University
  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center at Augusta University
        • Contact:
        • Contact:
          • Avirup Guha
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Contact:
          • Charles Porter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
Time Frame: 3-5 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
Time Frame: 3-5 years
The occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure.
3-5 years
Secondary Efficacy Outcome - Composite of Death, MI, Stroke
Time Frame: 3-5 years
The composite of cardiovascular death, myocardial infarction, or stroke.
3-5 years
Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
Time Frame: 3-5 years
The composite of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina.
3-5 years
Secondary Efficacy Outcome - Event Outcome - CV Death
Time Frame: 3-5 years
Cardiovascular death.
3-5 years
Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
Time Frame: 3-5 years
Myocardial infarction.
3-5 years
Secondary Efficacy Outcome - Event Outcome - Stroke
Time Frame: 3-5 years
Stroke.
3-5 years
Secondary Efficacy Outcome - Event Outcome - Heart Failure
Time Frame: 3-5 years
Heart failure.
3-5 years
Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism
Time Frame: 3-5 years
Venous Thromboembolism.
3-5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina
Time Frame: 3-5 years.
New or worsening angina.
3-5 years.
Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation
Time Frame: 3-5 years
New atrial fibrillation.
3-5 years
Tertiary Efficacy Outcomes - Cognitive Function
Time Frame: 3-5 years
Cognitive function, as measured by the DSS test.
3-5 years
Tertiary Efficacy Outcomes - Physical Measurement - Grip Strength
Time Frame: 3-5 years
Handgrip strength, as measured using the JAMAR Dynamometer.
3-5 years
Tertiary Efficacy Outcomes - Physical Measurement - Timed Walk Test
Time Frame: 3-5 years
Timed-get-up-and-go-test.
3-5 years
Tertiary Efficacy Outcomes - Physical Measurement - Walk Test
Time Frame: 3-5 years
Six-minute walk distance.
3-5 years
Tertiary Efficacy Outcomes - Physical Frailty
Time Frame: 3-5 years
Physical Frailty
3-5 years
Tertiary Efficacy Outcomes - Physical Measurement - Waist
Time Frame: 3-5 years
Waist circumference.
3-5 years
Tertiary Efficacy Outcomes - HbA1c
Time Frame: 3-5 years
HbA1c concentration.
3-5 years
Tertiary Efficacy Outcomes - Lipid Profile
Time Frame: 3-5 years
Lipid profile.
3-5 years
Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death
Time Frame: 3-5 years
Prostate cancer death.
3-5 years
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression
Time Frame: 3-5 years
Distant prostate cancer progression.
3-5 years
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC
Time Frame: 3-5 years
Development of castrate-resistant prostate cancer
3-5 years
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression
Time Frame: 3-5 years
PSA progression.
3-5 years
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure
Time Frame: 3-5 years
Biochemical failure.
3-5 years
Safety Outcome - Emergent Adverse Event - Major Bleeding
Time Frame: 3-5 years
Major bleeding.
3-5 years
Safety Outcome - Emergent Adverse Event - Myositis
Time Frame: 3-5 years
Myositis.
3-5 years
Safety Outcome - Emergent Adverse Event - Liver Injury
Time Frame: 3-5 years
Liver injury.
3-5 years
Safety Outcome - Emergent Adverse Event - Kidney Injury
Time Frame: 3-5 years
Kidney injury.
3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Cancer Society (CCS)
Prostate Cancer Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RADICALPC_009-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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