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Intervention for cardiovascular and lifestyle risks 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)

Not applicable Interventional McMaster University · NCT03127631

This study is testing whether a program that helps prostate cancer patients improve their diet, exercise, quit smoking, and manage medications can lower their heart disease risks and improve their overall health.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment6000 (estimated)
Ages45 Years and up
SexMale
SponsorMcMaster University Academic / other
Locations54 sites (Augusta, Georgia and 53 other locations)
Trial IDNCT03127631 on ClinicalTrials.gov

What this trial studies

This study involves two prospective studies focusing on men diagnosed with prostate cancer. The first part, RADICAL PC1, is a cohort study that aims to identify cardiovascular disease risk factors in men diagnosed within the past year or treated with Androgen Deprivation Therapy. The second part, RADICAL PC2, is a randomized controlled trial that tests a systematic approach to modifying cardiovascular and lifestyle risk factors through interventions such as nutrition, exercise, smoking cessation, and medication. The study seeks to improve health outcomes for prostate cancer patients by addressing these risk factors.

Who should consider this trial

Good fit: Ideal candidates are men diagnosed with prostate cancer within the past year or those who have recently started Androgen Deprivation Therapy.

Not a fit: Patients who are under 45 years old or have incidental prostate cancer found during bladder cancer surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular health and overall quality of life for prostate cancer patients.

How similar studies have performed: Other studies have shown promise in addressing cardiovascular risks in cancer patients, but this specific approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Augusta, Georgia and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerCardiovascular DiseaseAndrogen Deprivation Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.