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

Official Title

The Role of Androgen Deprivation Therapy In Cardiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC1) & A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICAL PC2)

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.

Trial Description

Primary Outcome:

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

Secondary Outcome:

• Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
• Secondary Efficacy Outcome - Composite of Death, MI, Stroke
• Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
• Secondary Efficacy Outcome - Event Outcome - CV Death
• Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
• Secondary Efficacy Outcome - Event Outcome - Stroke
• Secondary Efficacy Outcome - Event Outcome - Heart Failure
• Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism

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 who are within one month of commencing Androgen Deprivation Therapy for the first time. 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 who are within one month of commencing Androgen Deprivation Therapy for the first time.

View this trial on ClinicalTrials.gov