A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICALPC)
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ClinicalTrials.gov Identifier: NCT03127631 |
Recruitment Status : Unknown
Verified August 2018 by McMaster University.
Recruitment status was: Recruiting
First Posted : April 25, 2017
Last Update Posted : August 28, 2018
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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: Antiplatelet agent, such as Aspirin, or other low-dose antiplatelet agent 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) |
Study Start Date : | October 2015 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | September 2020 |

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 antiplatelet agents, 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: Antiplatelet agent, such as Aspirin, or other low-dose antiplatelet agent Prescription for a low-dose antiplatelet agent, such as aspirin 81-100mg daily or if intolerant of aspirin, other low-dose antiplatelet agent 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 >120mmHg, 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 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:
- Unwilling to provide consent, or
- Are <45 years of age
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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
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are undertaking all of the following:
- aspirin use, and
- statin use, and
- 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: Edith Wagan | 905-527-4322 ext 40495 | edith.wagan@phri.ca |
Canada, British Columbia | |
Vancouver General Hospital | Active, not recruiting |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Canada, Ontario | |
William Osler Health System | Recruiting |
Brampton, Ontario, Canada, L6R 3J7 | |
Contact: Achal Sharma achal.sharma@williamoslerhs.ca | |
Principal Investigator: Dr. Tamara Wallington, MD,FRCPC | |
St. Joseph's Healthcare | Recruiting |
Hamilton, Ontario, Canada, L8N4A6 | |
Contact: Aishwarya Sudakaran sudakaran@hhsc.ca | |
Principal Investigator: Dr. Bobby Shayegan, MD,FRCSC | |
Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V1C3 | |
Contact: Amanda Thiessen thiessena@hhsc.ca | |
Principal Investigator: Dr. Jehonathan Pinthus, MD,FRCS(C),PhD | |
Queen's University | Recruiting |
Kingston, Ontario, Canada, K7L 3J7 | |
Contact: Wendy Anstey, RN wendy.anstey@krcc.on.ca | |
Principal Investigator: Dr. Robert Siemens, MD,FRCSC | |
Grand River Hospital, Grand River Regional Cancer Centre | Recruiting |
Kitchener, Ontario, Canada, N2G 1G3 | |
Contact: Elyse Wellhauser Elyse.Wellhauser@grhosp.on.ca | |
Principal Investigator: Darin Gopaul, MD | |
London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 5W9 | |
Contact: Mounirah May mounirah.may@lhsc.ca | |
Principal Investigator: Dr. Patrick Luke, MD,FRCSC | |
London Health Sciences, Victoria Hospital | Recruiting |
London, Ontario, Canada, N6A 5W9 | |
Contact: Amanda Anderson Amanda.Anderson@lhsc.on.ca | |
Principal Investigator: Joseph Chin, MD, FRCSC | |
Niagara Health, St. Catharines Site | Active, not recruiting |
Niagara, Ontario, Canada, L2S 0A9 | |
Ottawa Hospital Research Institute | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Christopher Knee, ND, MSc cknee@ohri.ca | |
Principal Investigator: Dr. Luke Lavallee, MDCM,MSc,FRCSC | |
Sunnybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Marlene Kebabdjian marlene.kebabdjian@sunnybrook.ca | |
Principal Investigator: Dr. Laurence Klotz, MD,FRCS(C) | |
University Health Network, Princess Margaret Cancer Centre | Active, not recruiting |
Toronto, Ontario, Canada, M5G 2C1 | |
Canada, Quebec | |
University Hospital of Montreal | Recruiting |
Montreal, Quebec, Canada, H2X 0A9 | |
Contact: Roberta Carling roberta-daila.carling.chum@ssss.gouv.qc.ca | |
Principal Investigator: Dr. Emmanuelle Duceppe, MD,FRCPC | |
Jewish General Hospital | Recruiting |
Montreal, Quebec, Canada, H3T 1E2 | |
Contact: Amandine Laffitte amandine.laffitte.ccomtl@ssss.gouv.qc.ca | |
Principal Investigator: Dr. Tamim Niazi, MDCM | |
McGill University | Active, not recruiting |
Montréal, Quebec, Canada, H3A 0G4 | |
Laval University | Recruiting |
Quebec City, Quebec, Canada, G1V 0A6 | |
Contact: Denise St-Onge denise.st-onge@crchudequebec.ulaval.ca | |
Principal Investigator: Dr. Vincent Fradet, MD,PhD,FRCSC |
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: | August 28, 2018 |
Last Verified: | August 2018 |
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 Prostatic Diseases Aspirin Platelet Aggregation Inhibitors Atorvastatin Rosuvastatin Calcium Simvastatin Pravastatin Angiotensin-Converting Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Anticholesteremic Agents Hypolipidemic Agents |