A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICALPC)
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ClinicalTrials.gov Identifier: NCT03127631 |
Recruitment Status :
Recruiting
First Posted : April 25, 2017
Last Update Posted : October 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer Cardiovascular Disease | Behavioral: Nutrition Behavioral: Exercise Behavioral: Smoking cessation Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) Drug: ACE inhibitor | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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.
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- 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 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.
- Secondary Efficacy Outcome - Composite of Death, MI, Stroke [ Time Frame: 3-5 years ]The composite of cardiovascular death, myocardial infarction, or stroke.
- 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.
- Secondary Efficacy Outcome - Event Outcome - CV Death [ Time Frame: 3-5 years ]Cardiovascular death.
- Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction [ Time Frame: 3-5 years ]Myocardial infarction.
- Secondary Efficacy Outcome - Event Outcome - Stroke [ Time Frame: 3-5 years ]Stroke.
- Secondary Efficacy Outcome - Event Outcome - Heart Failure [ Time Frame: 3-5 years ]Heart failure.
- Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism [ Time Frame: 3-5 years ]Venous Thromboembolism.
- Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina [ Time Frame: 3-5 years. ]New or worsening angina.
- Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation [ Time Frame: 3-5 years ]New atrial fibrillation.
- Tertiary Efficacy Outcomes - Cognitive Function [ Time Frame: 3-5 years ]Cognitive function, as measured by the DSS test.
- Tertiary Efficacy Outcomes - Physical Measurement - Grip Strength [ Time Frame: 3-5 years ]Handgrip strength, as measured using the JAMAR Dynamometer.
- Tertiary Efficacy Outcomes - Physical Measurement - Timed Walk Test [ Time Frame: 3-5 years ]Timed-get-up-and-go-test.
- Tertiary Efficacy Outcomes - Physical Measurement - Walk Test [ Time Frame: 3-5 years ]Six-minute walk distance.
- Tertiary Efficacy Outcomes - Physical Frailty [ Time Frame: 3-5 years ]Physical Frailty
- Tertiary Efficacy Outcomes - Physical Measurement - Waist [ Time Frame: 3-5 years ]Waist circumference.
- Tertiary Efficacy Outcomes - HbA1c [ Time Frame: 3-5 years ]HbA1c concentration.
- Tertiary Efficacy Outcomes - Lipid Profile [ Time Frame: 3-5 years ]Lipid profile.
- Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death [ Time Frame: 3-5 years ]Prostate cancer death.
- Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression [ Time Frame: 3-5 years ]Distant prostate cancer progression.
- Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC [ Time Frame: 3-5 years ]Development of castrate-resistant prostate cancer
- Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression [ Time Frame: 3-5 years ]PSA progression.
- Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure [ Time Frame: 3-5 years ]Biochemical failure.
- Safety Outcome - Emergent Adverse Event - Major Bleeding [ Time Frame: 3-5 years ]Major bleeding.
- Safety Outcome - Emergent Adverse Event - Myositis [ Time Frame: 3-5 years ]Myositis.
- Safety Outcome - Emergent Adverse Event - Liver Injury [ Time Frame: 3-5 years ]Liver injury.
- Safety Outcome - Emergent Adverse Event - Kidney Injury [ Time Frame: 3-5 years ]Kidney injury.

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.
Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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:
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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
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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

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
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 |

Study Director: | Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC | McMaster University |
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 |
Androgen Deprivation Therapy |
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 |