A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients

Conditions

Prostate Cancer, Cardiovascular Disease

Keywords

Androgen Deprivation Therapy

Brief 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.

Baskaran G, Pinthus JH, Karampatos S, Ng KKH, Garcia CC, Mian R, Pyne L, Brimble S, Klotz LH, Fradet V, Selvanayagam JB, Guha A, Higano CS, Avezum Á, Hajjar LA, Cavalli GD, Valle FH, Duceppe E, Dusilek CDOL, Shayegan B, Piccoli RK, Gomez-Mesa J, Niazi T, Davis MK, Cita Pardo JE, Luke PP, Leong D, RADICAL PC Investigators.

2026-03-10

10.1007/s11255-026-05085-5

Investigation of association between clinically significant prostate cancer, obesity and platelet to-lymphocyte ratio and neutrophil -to-lymphocyte ratio.

Dahan J, Pinthus J, Delouya G, Taussky D, Duceppe E, de Jesus A, Leong D.

2024-10-161 citations

10.1186/s12894-024-01617-2

Development and Comparability of a Short Food-Frequency Questionnaire to Assess Diet in Prostate Cancer Patients: The Role of Androgen Deprivation Therapy in CArdiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC) Substudy.

Savija N, Leong DP, Pinthus J, Karampatos S, Shayegan B, Mian R, Rangarajan S, Fradet V, de Souza RJ, Mente A, Dehghan M.

2021-08-124 citations

10.1093/cdn/nzab106

The prevalence of cardiovascular disease and its risk factors among prostate cancer patients treated with and without androgen deprivation.

Jehonathan H. Pinthus, Bobby Shayegan, Laurence Klotz, D. Robert Siemens, Patrick Luke et al. (21 authors)

Journal of Clinical Oncology2020-02-1910 citations

10.1200/jco.2020.38.6_suppl.364

Interventions

BEHAVIORALNutrition

Standardized advice on healthy diet practices.

BEHAVIORALExercise

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

BEHAVIORALSmoking cessation

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

DRUGStatin (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.

DRUGACE 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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.	3-5 years	The primary efficacy outcome is the occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization.

Secondary

Measure	Time frame	Description
Secondary Efficacy Outcome - Composite of Death, MI, Stroke	3-5 years	The composite of cardiovascular death, myocardial infarction, or stroke.
Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.	3-5 years	The composite of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina.
Secondary Efficacy Outcome - Event Outcome - CV Death	3-5 years	Cardiovascular death.
Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.	3-5 years	The occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure.
Secondary Efficacy Outcome - Event Outcome - Stroke	3-5 years	Stroke.
Secondary Efficacy Outcome - Event Outcome - Heart Failure	3-5 years	Heart failure.
Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism	3-5 years	Venous Thromboembolism.
Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction	3-5 years	Myocardial infarction.

Other

Measure	Time frame	Description
Safety Outcome - Emergent Adverse Event - Liver Injury	3-5 years	Liver injury.
Tertiary Efficacy Outcomes - Physical Measurement - Timed Walk Test	3-5 years	Timed-get-up-and-go-test.
Tertiary Efficacy Outcomes - Physical Measurement - Walk Test	3-5 years	Six-minute walk distance.
Tertiary Efficacy Outcomes - Physical Frailty	3-5 years	Physical Frailty
Tertiary Efficacy Outcomes - Physical Measurement - Waist	3-5 years	Waist circumference.
Tertiary Efficacy Outcomes - Lipid Profile	3-5 years	Lipid profile.
Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina	3-5 years.	New or worsening angina.
Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation	3-5 years	New atrial fibrillation.
Tertiary Efficacy Outcomes - Cognitive Function	3-5 years	Cognitive function, as measured by the DSS test.
Tertiary Efficacy Outcomes - Physical Measurement - Grip Strength	3-5 years	Handgrip strength, as measured using the JAMAR Dynamometer.
Tertiary Efficacy Outcomes - HbA1c	3-5 years	HbA1c concentration.
Safety Outcome - Emergent Adverse Event - Kidney Injury	3-5 years	Kidney injury.
Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death	3-5 years	Prostate cancer death.
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression	3-5 years	Distant prostate cancer progression.
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC	3-5 years	Development of castrate-resistant prostate cancer
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression	3-5 years	PSA progression.
Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure	3-5 years	Biochemical failure.
Safety Outcome - Emergent Adverse Event - Major Bleeding	3-5 years	Major bleeding.
Safety Outcome - Emergent Adverse Event - Myositis	3-5 years	Myositis.

Countries

Australia, Brazil, Canada, Colombia, Israel, Turkey (Türkiye), United States

Contacts

Primary ContactSarah Karampatos, BASc, MSc

sarah.karampatos@phri.ca905-527-4322

Backup ContactSteven Agapay, BSc

steve.agapay@phri.ca905-296-5764

Outcome results

None listed