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

• Sponsor: McMaster University
• Collaborator: Prostate Cancer Canada
• Information provided by (Responsible Party): McMaster University

Study Description

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: Antiplatelet agent, such as Aspirin, or other low-dose antiplatelet agent; 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 who are within one month of commencing Androgen Deprivation Therapy for the first time. 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 who are within one month of commencing Androgen Deprivation Therapy for the first time.

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)
Study Start Date :	October 2015
Estimated Primary Completion Date :	September 2020
Estimated Study Completion Date :	September 2020

Arms and Interventions

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 antiplatelet agents, 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: 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.

Outcome Measures

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 Measurement - Waist [ Time Frame: 3-5 years ]
   Waist circumference.
8. Tertiary Efficacy Outcomes - HbA1c [ Time Frame: 3-5 years ]
   HbA1c concentration.
9. Tertiary Efficacy Outcomes - Lipid Profile [ Time Frame: 3-5 years ]
   Lipid profile.
10. Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death [ Time Frame: 3-5 years ]
    Prostate cancer death.
11. Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression [ Time Frame: 3-5 years ]
    Distant prostate cancer progression.
12. Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC [ Time Frame: 3-5 years ]
    Development of castrate-resistant prostate cancer
13. Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression [ Time Frame: 3-5 years ]
    PSA progression.
14. Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure [ Time Frame: 3-5 years ]
    Biochemical failure.
15. Safety Outcome - Emergent Adverse Event - Major Bleeding [ Time Frame: 3-5 years ]
    Major bleeding.
16. Safety Outcome - Emergent Adverse Event - Myositis [ Time Frame: 3-5 years ]
    Myositis.
17. Safety Outcome - Emergent Adverse Event - Liver Injury [ Time Frame: 3-5 years ]
    Liver injury.
18. Safety Outcome - Emergent Adverse Event - Kidney Injury [ Time Frame: 3-5 years ]
    Kidney injury.

Eligibility Criteria

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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. Unwilling to provide consent, or
2. Are <45 years of age

3. Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:

   • see a cardiologist every year, or

   • are undertaking all of the following:

     • aspirin use, and
     • statin use, and
     • systolic blood pressure ≤130mmHg

Contacts and Locations

Contacts

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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

Locations

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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

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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Responsible Party:	McMaster University
ClinicalTrials.gov Identifier:	NCT03127631 History of Changes
Other Study ID Numbers:	RADICALPC_009-001
First Posted:	April 25, 2017
Last Update Posted:	August 28, 2018
Last Verified:	August 2018
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; Prostatic Diseases; Aspirin; Platelet Aggregation Inhibitors; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Pravastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Androgens; 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