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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-5 years

Awards & highlights

RADICALPC Trial 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.Check my eligibility

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.See study design

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.

RADICALPC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 outcome measures

Safety Outcome - Emergent Adverse Event - Kidney Injury

Safety Outcome - Emergent Adverse Event - Liver Injury

Safety Outcome - Emergent Adverse Event - Major Bleeding

+16 more

RADICALPC 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Canadian Cancer Society (CCS)OTHER

78 Previous Clinical Trials

31,745 Total Patients Enrolled

7 Trials studying Prostate Cancer

1,625 Patients Enrolled for Prostate Cancer

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,591,886 Total Patients Enrolled

4 Trials studying Prostate Cancer

1,149 Patients Enrolled for Prostate Cancer

Prostate Cancer CanadaOTHER

9 Previous Clinical Trials

1,526 Total Patients Enrolled

6 Trials studying Prostate Cancer

1,282 Patients Enrolled for Prostate Cancer

Media Library

Randomized - Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03127631 — N/A

Prostate Cancer Research Study Groups: Randomized - Intervention, Randomized - Control

Prostate Cancer Clinical Trial 2023: Randomized - Intervention Highlights & Side Effects. Trial Name: NCT03127631 — N/A

Randomized - Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03127631 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are typically addressed through Randomized - Intervention?

"Randomized - Intervention is a successful form of treatment for coronary heart disease, synovitis and anxiety which have been diagnosed by medical professionals."

Answered by AI

Is recruitment still open for this experiment?

"Affirmative. Clinicaltrials.gov data indicates that the trial, first posted on October 21st 2015 andupdatedonOctober 3rd 2022, is actively enrolling patients for participation. 6000 participants are being sought from 16 different locations across the country."

Answered by AI

How many venues is this research conducted in?

"This trial has 16 available sites, including Jewish General Hospital in Montreal, Centre Universitaire de Sherbrooke in Sherbrooke and Niagara Health, St. Catharines Site in Niagara among others."

Answered by AI

What prior experiments have utilized a Randomized - Intervention protocol?

"Back in 2005, the Vermont Cancer Center was one of the first sites to run a Randomized - Intervention trial. Since then it has been repeated 2092 times and currently there are 298 active studies across Montreal, Ontario."

Answered by AI

How many individuals are actively partaking in this clinical trial?

"Affirmative. Clinicaltrials.gov details that this clinical trial is currently enrolling, beginning on the 21st October 2015 and last edited the 3rd of October 2022. The research necessitates 6000 participants from 16 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03127631.

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