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

Sponsor

McMaster University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03127631

Collaborator

Prostate Cancer Canada (Other)

6,000

Enrollment

Locations

Arms

Duration (Months)

375

Patients Per Site

6.4

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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 :

Oct 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 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.

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

Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc. [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

Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF. [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 [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. [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 [3-5 years]
Cardiovascular death.
Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction [3-5 years]
Myocardial infarction.
Secondary Efficacy Outcome - Event Outcome - Stroke [3-5 years]
Stroke.
Secondary Efficacy Outcome - Event Outcome - Heart Failure [3-5 years]
Heart failure.
Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism [3-5 years]
Venous Thromboembolism.

Other Outcome Measures

Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina [3-5 years.]
New or worsening angina.
Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation [3-5 years]
New atrial fibrillation.
Tertiary Efficacy Outcomes - Cognitive Function [3-5 years]
Cognitive function, as measured by the DSS test.
Tertiary Efficacy Outcomes - Physical Measurement - Grip Strength [3-5 years]
Handgrip strength, as measured using the JAMAR Dynamometer.
Tertiary Efficacy Outcomes - Physical Measurement - Timed Walk Test [3-5 years]
Timed-get-up-and-go-test.
Tertiary Efficacy Outcomes - Physical Measurement - Walk Test [3-5 years]
Six-minute walk distance.
Tertiary Efficacy Outcomes - Physical Measurement - Waist [3-5 years]
Waist circumference.
Tertiary Efficacy Outcomes - HbA1c [3-5 years]
HbA1c concentration.
Tertiary Efficacy Outcomes - Lipid Profile [3-5 years]
Lipid profile.
Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death [3-5 years]
Prostate cancer death.
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression [3-5 years]
Distant prostate cancer progression.
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC [3-5 years]
Development of castrate-resistant prostate cancer
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression [3-5 years]
PSA progression.
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure [3-5 years]
Biochemical failure.
Safety Outcome - Emergent Adverse Event - Major Bleeding [3-5 years]
Major bleeding.
Safety Outcome - Emergent Adverse Event - Myositis [3-5 years]
Myositis.
Safety Outcome - Emergent Adverse Event - Liver Injury [3-5 years]
Liver injury.
Safety Outcome - Emergent Adverse Event - Kidney Injury [3-5 years]
Kidney injury.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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

Locations

	Site	City	State	Country	Postal Code
1	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9
2	William Osler Health System	Brampton	Ontario	Canada	L6R 3J7
3	St. Joseph's Healthcare	Hamilton	Ontario	Canada	L8N4A6
4	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V1C3
5	Queen's University	Kingston	Ontario	Canada	K7L 3J7
6	Grand River Hospital, Grand River Regional Cancer Centre	Kitchener	Ontario	Canada	N2G 1G3
7	London Health Sciences Centre	London	Ontario	Canada	N6A 5W9
8	London Health Sciences, Victoria Hospital	London	Ontario	Canada	N6A 5W9
9	Niagara Health, St. Catharines Site	Niagara	Ontario	Canada	L2S 0A9
10	Ottawa Hospital Research Institute	Ottawa	Ontario	Canada	K1H 8L6
11	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
12	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2C1
13	University Hospital of Montreal	Montreal	Quebec	Canada	H2X 0A9
14	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
15	McGill University	Montréal	Quebec	Canada	H3A 0G4
16	Laval University	Quebec City	Quebec	Canada	G1V 0A6