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Lifestyle Changes and Medications for Prostate Cancer (RADICALPC Trial)

N/A

Recruiting

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients will be excluded if they fulfill any of the following: are unwilling to provide consent or are <45 years of age, or prostate cancer was found incidentally following cystectomy for bladder cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether modifying risk factors can reduce the risk of prostate cancer progression.

Who is the study for?

Men recently diagnosed with prostate cancer or starting Androgen Deprivation Therapy can join. It's not for those under 45, seeing a cardiologist yearly, on statins with low blood pressure, or whose cancer was found after bladder surgery.

What is being tested?

The RADICAL PC2 trial tests a systematic approach to improve heart health and lifestyle in men newly diagnosed with prostate cancer through medications like statins and ACE inhibitors, plus exercise, diet changes, and smoking cessation.

What are the potential side effects?

Possible side effects include muscle pain from statins; cough or increased potassium levels from ACE inhibitors; injury from exercise; and nicotine withdrawal symptoms from quitting smoking.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am over 45, willing to consent, and my prostate cancer was not found by accident after bladder surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Secondary Efficacy Outcome - Composite of Death, MI, Stroke

Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.

Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.

+5 more

Other study objectives

Safety Outcome - Emergent Adverse Event - Kidney Injury

Safety Outcome - Emergent Adverse Event - Liver Injury

Safety Outcome - Emergent Adverse Event - Major Bleeding

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Randomized - InterventionActive Control5 Interventions

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.

Group II: Randomized - ControlActive Control1 Intervention

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.

0 / 1Eligibility criteria met