Projects

Projects

RADICAL PC1- Role of Androgen Deprivation Therapy In CArdiovascular Disease – A Longitudinal Prostate Cancer Study. RADICAL PC2- A RAndomizeD Intervention for CArdiovascular and Lifestyle Risk Factors in Prostate Cancer Patients.

Details

Description:

a) Background: This is an international, multi-center study of men diagnosed with prostate cancer and includes an observational study and a Randomized Controlled Trial (RCT). The two studies are:

1. RADICAL PC1- It is a prospective cohort study of men with a new diagnosis of prostate cancer who will be followed up for 5 years.
2. RADICAL PC2- It 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.

b) Aim/objective:

RADICAL PC1

1. To determine:

1. the prevalence of CVD risk factors and disease, and
2. the incidence of adverse CVD events

2. To evaluate the relationship of ADT with adverse CVD events
3. To identify factors (clinical factors and PC treatments) that are independently associated with the development of CVD in men with PC

RADICAL PC2

Primary: To determine whether a systematic CV and lifestyle risk factor modification strategy reduces the risk of CVD in men with a new diagnosis of PC

Secondary

1. To determine whether a systematic CV and lifestyle risk factor modification strategy improves the CV risk profile. To estimate the incremental cost-effectiveness ratio of a systematic CV and lifestyle risk factor modification strategy.

e) Sample size: The study targets to include at least 6000 participants globally. India will contribute approximately 500 participants with equal numbers of 250 each in Cohort study and the RCT respectively.

f) Study update as on 14 Dec 23:

A total number of seven sites across India have been identified to conduct the study. Process of obtaining regulatory approvals is under way.

Updated as on : 16th Dec 2023