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

McMaster University

Status: Enrolling

Conditions: Prostate Cancer; Cardiovascular Disease

Treatments: Behavioral: Smoking cessation; Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin); Behavioral: Nutrition; Behavioral: Exercise; Drug: ACE inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03127631

RADICALPC_009-001

Details and patient eligibility

About

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.

Full 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 treated with Androgen Deprivation Therapy for the first time within 6 months prior to enrollment visit, or to be treated with Androgen Deprivation Therapy for the first time within one month after the enrollment visit. 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 treated with Androgen Deprivation Therapy for the first time within 6 months prior to enrollment visit, or to be treated with Androgen Deprivation Therapy for the first time within one month after the enrollment visit.

Enrollment: 6,000 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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. Patients will be excluded if they fulfill any of the following:

   1. are unwilling to provide consent or
   2. are <45 years of age, or
   3. prostate cancer was found incidentally following cystectomy for bladder cancer

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

   1. see a cardiologist every year, or
   2. both take a statin and have systolic blood pressure ≤130mmHg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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6,000 participants in 2 patient groups

Randomized - Intervention

Active Comparator group

Description:

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.

Treatment:

Drug: ACE inhibitor

Behavioral: Exercise

Behavioral: Nutrition

Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)

Behavioral: Smoking cessation

Randomized - Control

No Intervention group

Description:

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.