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NCT Number: NCT03127631

A Study for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Cardiovascular Disease Cardiovascular Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Hospital, Westmead, New South Wales, Australia

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About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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

Treatment and study plan

Nutrition

Behavioral

Standardized advice on healthy diet practices.

Exercise

Behavioral

Standardized advice on exercise including strength training and resistance training exercises.

smoking cessation

Behavioral

Advice to quit smoking, if applicable, and on available aids to quit smoking,

Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)

Drug

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.

ACE inhibitor

Drug

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.

Primary outcomes

  1. Hierarchical composite of cardiovascular death, myocardial infarction, stroke, heart failure, cholesterol control (defined as total cholesterol ≤4mmol/L) and systolic blood pressure control (defined as systolic blood pressure ≤130mmHg).

    Time frame: 3-5 years

    Hierarchical composite of cardiovascular death, myocardial infarction, stroke, heart failure, cholesterol control (defined as total cholesterol ≤4mmol/L) and systolic blood pressure control (defined as systolic blood pressure ≤130mmHg).

  2. Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.

    Time frame: 3-5 years

    Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.

Other outcomes

  1. Exploratory Analyses Endpoint - Systolic Blood Pressure

    Time frame: 3-5 years

    Measure of systolic blood pressure

  2. Exploratory Analyses Endpoint - Total and Low-Density Lipoprotein Cholesterol

    Time frame: 3-5 years

    Measure of total and low-density lipoprotein cholesterol

  3. Exploratory Analyses Endpoint - Hemoglobin A1c Concentration

    Time frame: 3-5 years

    Hemoglobin A1c concentration

  4. Exploratory Analyses Endpoint - Handgrip Strength

    Time frame: 3-5 years

    Measure of handgrip strength

  5. Exploratory Analyses Endpoint - Get-Up-and-Go Time

    Time frame: 3-5 years

    Timed get-up-and-go test

  6. Exploratory Analyses Endpoint - Waist Circumference

    Time frame: 3-5 years

    Measure of waist circumference

  7. Exploratory Analyses Endpoint - Six-Minute Walk Distance

    Time frame: 3-5 years

    Distance walked in six minutes

  8. Exploratory Analyses Endpoint - Digital Symbol Substitution (DSS) Test

    Time frame: 3-5 years

    Digital symbol substitution (DSS) test score

  9. Safety Outcome - Emergent Adverse Event - Major Bleeding

    Time frame: 3-5 years

    Major bleeding.

  10. Safety Outcome - Emergent Adverse Event - Myositis

    Time frame: 3-5 years

    Myositis.

  11. Safety Outcome - Emergent Adverse Event - Liver Injury

    Time frame: 3-5 years

    Liver injury.

  12. Safety Outcome - Emergent Adverse Event - Kidney Injury

    Time frame: 3-5 years

    Kidney injury.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Cancer Society (CCS)
  • Prostate Cancer Canada
  • Tolmar Inc.

Registry information

Official study title

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)

Acronym: RADICALPC

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2017
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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