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Not recruiting

Cardiovascular Intervention

Sponsor:

McMaster University

Code:

NCT03127631

Conditions

Prostate Cancer

Cardiovascular Disease

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Nutrition

Exercise

Smoking cessation

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

ACE inhibitor

Study Details

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.

Conditions

Prostate Cancer

Cardiovascular Disease

Study ID

NCT03127631

Start date

Oct 21, 2015

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Nutrition

Standardized advice on healthy diet practices.

Exercise

Standardized advice on exercise including strength training and resistance training exercises.

Smoking cessation

Advice to quit smoking, if applicable, and on available aids to quit smoking,

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.

ACE inhibitor

Prescription for an ACE-I (preferable) or an angiotensin receptor blocker for baseline systolic blood pressure greater >130mmHg, or other blood pressure lowering medication as applicable.

Primary outcome measure

  • Primary Endpoint - Time to first occurrence of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization. [ Time Frame: 3-5 years ]

Central Contacts and Locations

More Information

Sponsor

McMaster University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Androgen Deprivation Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by McMaster University on 2026-06-22.