A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
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)
McMaster University
6,000 participants
Oct 21, 2015
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- \. 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 Criteria7
- Patients will be excluded if they fulfill any of the following:
- are unwilling to provide consent or
- are \<45 years of age, or
- prostate cancer was found incidentally following cystectomy for bladder cancer
- Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
- see a cardiologist every year, or
- both take a statin and have systolic blood pressure ≤130mmHg
Interventions
Standardized advice on healthy diet practices.
Standardized advice on exercise including strength training and resistance training exercises.
Advice to quit smoking, if applicable, and on available aids to quit smoking,
Prescription for a low to moderate dose statin, such as simvastatin 10-40mg daily, atorvastatin 10-40mg daily, rosuvastatin 5-20mg daily or pravastatin 10-40mg daily.
Prescription for an ACE-I (preferable) or an angiotensin receptor blocker for baseline systolic blood pressure greater \>130mmHg, or other blood pressure lowering medication as applicable.
Locations(54)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03127631