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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

treated with Androgen Deprivation Therapy for the first time within 6 months prior to the enrolment visit

to be treated with Androgen Deprivation Therapy for the first time within 1 month after the enrolment visit

Exclusion criteria

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

are unwilling to provide consent

are <45 years of age

prostate cancer was found incidentally following cystectomy for bladder cancer

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

see a cardiologist every year

both take a statin and have systolic blood pressure ≤130mmHg

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Eligibility

Age eligible for study : 45 and older

Healthy volunteers accepted : No

Gender eligible for study: Male

Things to know

Study dates

Study start: 2015-10-21

Primary completion: 2025-12-01

Study completion finish: 2025-12-01

Study type

TREATMENT

Phase

Trial ID

NCT03127631

Intervention or treatment

BEHAVIORAL: Nutrition

BEHAVIORAL: Exercise

BEHAVIORAL: Smoking cessation

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

DRUG: ACE inhibitor

Conditions

• Prostate Cancer
• Cardiovascular Disease

Condition: Prostate Cancer, Cardiovascular Disease
BEHAVIORAL: Nutrition and other drugs
Westmead, New South Wales, Australia and more
Sponsor: McMaster University

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Find a site

Closest Location:

Westmead Hospital

Research sites nearby

Select from list below to view details:

Westmead Hospital
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Flinders Medical Center
Adelaide, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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 statins, ACE-I, and other antihypertensive medications where appropriate.	BEHAVIORAL: Nutrition Standardized advice on healthy diet practices.
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.	Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.	The primary efficacy outcome is the occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization.	3-5 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.	The occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure.	3-5 years
Secondary Efficacy Outcome - Composite of Death, MI, Stroke	The composite of cardiovascular death, myocardial infarction, or stroke.	3-5 years
Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.	The composite of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina.	3-5 years
Secondary Efficacy Outcome - Event Outcome - CV Death	Cardiovascular death.	3-5 years
Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction	Myocardial infarction.	3-5 years
Secondary Efficacy Outcome - Event Outcome - Stroke	Stroke.	3-5 years
Secondary Efficacy Outcome - Event Outcome - Heart Failure	Heart failure.	3-5 years
Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism	Venous Thromboembolism.	3-5 years

Frequently Asked Questions

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References

Clinical Trials Gov: A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients