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

• ClinicalTrials.gov Identifier: NCT03127631
• Recruitment Status: Recruiting
• First Posted: April 25, 2017
• Last Update Posted: August 28, 2018
• 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

• 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

• 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

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

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

• Study Director: Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC; McMaster University

More Information

• Responsible Party: McMaster University
• ClinicalTrials.gov Identifier: NCT03127631
• 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:

Prostatic Neoplasms; Cardiovascular Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Aspirin; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Pravastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Platelet Aggregation 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