NCT03127631

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	Nutrition	Standardized advice on healthy diet practices.
BEHAVIORAL	Exercise	Standardized advice on exercise including strength training and resistance training exercises.
BEHAVIORAL	Smoking cessation	Advice to quit smoking, if applicable, and on available aids to quit smoking,
DRUG	Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)	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.
DRUG	ACE inhibitor	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.

Timeline

• Start date: 2015-10-21
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-04-25
• Last updated: 2025-01-31

Locations

54 sites across 7 countries: United States, Australia, Brazil, Canada, Colombia, Israel, Turkey (Türkiye)