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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03127631
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : October 4, 2022
Sponsor:
Collaborator:
Prostate Cancer Canada
Information provided by (Responsible Party):
McMaster University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Cardiovascular Disease Behavioral: Nutrition Behavioral: Exercise Behavioral: Smoking cessation Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) Drug: ACE inhibitor Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 21, 2015
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Secondary Efficacy Outcome - Composite of Death, MI, Stroke [ Time Frame: 3-5 years ]
    The composite of cardiovascular death, myocardial infarction, or stroke.

  3. 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.

  4. Secondary Efficacy Outcome - Event Outcome - CV Death [ Time Frame: 3-5 years ]
    Cardiovascular death.

  5. Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction [ Time Frame: 3-5 years ]
    Myocardial infarction.

  6. Secondary Efficacy Outcome - Event Outcome - Stroke [ Time Frame: 3-5 years ]
    Stroke.

  7. Secondary Efficacy Outcome - Event Outcome - Heart Failure [ Time Frame: 3-5 years ]
    Heart failure.

  8. Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism [ Time Frame: 3-5 years ]
    Venous Thromboembolism.


Other Outcome Measures:
  1. Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina [ Time Frame: 3-5 years. ]
    New or worsening angina.

  2. Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation [ Time Frame: 3-5 years ]
    New atrial fibrillation.

  3. Tertiary Efficacy Outcomes - Cognitive Function [ Time Frame: 3-5 years ]
    Cognitive function, as measured by the DSS test.

  4. Tertiary Efficacy Outcomes - Physical Measurement - Grip Strength [ Time Frame: 3-5 years ]
    Handgrip strength, as measured using the JAMAR Dynamometer.

  5. Tertiary Efficacy Outcomes - Physical Measurement - Timed Walk Test [ Time Frame: 3-5 years ]
    Timed-get-up-and-go-test.

  6. Tertiary Efficacy Outcomes - Physical Measurement - Walk Test [ Time Frame: 3-5 years ]
    Six-minute walk distance.

  7. Tertiary Efficacy Outcomes - Physical Frailty [ Time Frame: 3-5 years ]
    Physical Frailty

  8. Tertiary Efficacy Outcomes - Physical Measurement - Waist [ Time Frame: 3-5 years ]
    Waist circumference.

  9. Tertiary Efficacy Outcomes - HbA1c [ Time Frame: 3-5 years ]
    HbA1c concentration.

  10. Tertiary Efficacy Outcomes - Lipid Profile [ Time Frame: 3-5 years ]
    Lipid profile.

  11. Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death [ Time Frame: 3-5 years ]
    Prostate cancer death.

  12. Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression [ Time Frame: 3-5 years ]
    Distant prostate cancer progression.

  13. Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC [ Time Frame: 3-5 years ]
    Development of castrate-resistant prostate cancer

  14. Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression [ Time Frame: 3-5 years ]
    PSA progression.

  15. Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure [ Time Frame: 3-5 years ]
    Biochemical failure.

  16. Safety Outcome - Emergent Adverse Event - Major Bleeding [ Time Frame: 3-5 years ]
    Major bleeding.

  17. Safety Outcome - Emergent Adverse Event - Myositis [ Time Frame: 3-5 years ]
    Myositis.

  18. Safety Outcome - Emergent Adverse Event - Liver Injury [ Time Frame: 3-5 years ]
    Liver injury.

  19. Safety Outcome - Emergent Adverse Event - Kidney Injury [ Time Frame: 3-5 years ]
    Kidney injury.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127631


Contacts
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Contact: Sarah Karampatos, BASc, MSc 905-527-4322 ext 40506 sarah.karampatos@phri.ca
Contact: Steven Agapay, BSc 905-527-4322 ext 40536 steve.agapay@phri.ca

Locations
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Sponsors and Collaborators
McMaster University
Prostate Cancer Canada
Investigators
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Study Director: Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC McMaster University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03127631    
Other Study ID Numbers: RADICALPC_009-001
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by McMaster University:
Androgen Deprivation Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Cardiovascular Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Atorvastatin
 Rosuvastatin Calcium
Simvastatin
Pravastatin
Angiotensin-Converting Enzyme Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Protease Inhibitors