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

Conditions

Cardiovascular Disease, Prostate Cancer

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
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).	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).
Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.	3-5 years	Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure.

Countries

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

Contacts

STUDY_DIRECTORDr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC

McMaster University

Outcome results

None listed