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Recruiting Not applicable NCT03127631

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

No applicable phase (e.g. observational)
Conditions: Prostate Cancer Cardiovascular Disease

Sponsor: McMaster University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Locations 7
Australia (1)
Westmead Hospital
Westmead , New South Wales
Brazil (1)
Centro de Pesquisa Clínica do Brasil
Brasília , Federal District
Canada (1)
Vancouver General Hospital
Vancouver , British Columbia
Colombia (1)
Hospital Universitario San Ignacio
Bogotá , Cundinamarca
NOT_YET_RECRUITING
Katherine Castrillon Velez
Israel (1)
Heart Institute - Holon Medical Center
Holon
Turkey (1)
Istanbul University
Istanbul
TERMINATED
United States (1)
Georgia Cancer Center at Augusta University
Augusta , Georgia
Hyma Kunhiraman Harikrishnan
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
45 Years
Healthy volunteers
No
Start date
21.10.2015
Completion date
01.12.2026
Registry ID
NCT03127631
Source
anzctr
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