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

Clinicaltrials.gov ID: NCT03127631
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 45 Years
b-bullseye-arrow Enrollments 6000

Conditions

Prostate Cancer, Cardiovascular Disease

Drugs

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

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.

Detailed 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.

Locations

2 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

Study Director

  • Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC

Status

  • RECRUITING

Contact Person

Study Director

  • Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC

Eligibility Criteria

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

Outcome Measures

Primary Outcome Measures

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

Time Frame: 3-5 years

Secondary Outcome Measures

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

Time Frame: 3-5 years

Secondary Efficacy Outcome - Composite of Death, MI, Stroke

Time Frame: 3-5 years

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

Time Frame: 3-5 years

Secondary Efficacy Outcome - Event Outcome - CV Death

Time Frame: 3-5 years

Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction

Time Frame: 3-5 years

Secondary Efficacy Outcome - Event Outcome - Stroke

Time Frame: 3-5 years

Secondary Efficacy Outcome - Event Outcome - Heart Failure

Time Frame: 3-5 years

Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism

Time Frame: 3-5 years

Timeline

  • Last Updated
    September 21, 2023
  • Start Date
    April 25, 2017
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 1, 2025

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