A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
Status
RECRUITING
Phase
NA
Age
≥ 45 Years
Enrollments
6000Conditions
Prostate Cancer, Cardiovascular DiseaseDrugs
Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin), ACE inhibitorSummary
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
- Priyanshu Nain
- [email protected]
Study Director
- Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
Status
- RECRUITING
Contact Person
- Terry Christenson
- [email protected]
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.
Secondary Outcome Measures
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
Timeline
Last Updated
September 21, 2023Start Date
April 25, 2017Today
February 5, 2025Completion Date ( Estimated )
December 1, 2025
Sponsors of this trial
Lead Sponsor
McMaster UniversityCollaborating Sponsors
Prostate Cancer Canada, Canadian Cancer Society (CCS)
RECRUITING 
21 - 64 Years