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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Prostate Cancer, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Nutrition
* Behavioral: Exercise
* Behavioral: Smoking cessation
* Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
* Drug: ACE inhibitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Randomized - Intervention<br>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<br>* Standardized advice on healthy diet practices.<br>Behavioral: Exercise<br>* Standardized advice on exercise including strength training and resistance training exercises.<br>Behavioral: Smoking cessation<br>* Advice to quit smoking, if applicable, and on available aids to quit smoking,<br>Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)<br>* 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.<br>Drug: ACE inhibitor<br>* 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.<br>|
| No Intervention: Randomized - Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3-5 years | 
| Secondary Efficacy Outcome - Composite of Death, MI, Stroke | 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. | 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 | Cardiovascular death. | 3-5 years | 
| Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction | Myocardial infarction. | 3-5 years | 
| Secondary Efficacy Outcome - Event Outcome - Stroke | Stroke. | 3-5 years | 
| Secondary Efficacy Outcome - Event Outcome - Heart Failure | Heart failure. | 3-5 years | 
| Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism | Venous Thromboembolism. | 3-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgen Deprivation Therapy