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

Prostate Cancer Clinical Trial

— RADICALPC  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03127631
• Other study ID #: RADICALPC_009-001
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2015
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: McMaster University
• Contact: Sarah Karampatos, BASc, MSc
• Phone: 905-527-4322
• Email: sarah.karampatos[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Nutrition
Standardized advice on healthy diet practices.
• Exercise
Standardized advice on exercise including strength training and resistance training exercises.
• Smoking cessation
Advice to quit smoking, if applicable, and on available aids to quit smoking,

Drug:
• Statin (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.
• ACE 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.

Locations

Country	Name	City	State
Australia	Flinders Medical Center	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Brazil	Hospital Felício Rocho	Belo Horizonte	Minas Gerais
Brazil	Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP	Botucatu	São Paulo
Brazil	Hospital Universitário São Francisco na Providência de Deus	Bragança Paulista	São Paulo
Brazil	Centro de Pesquisa Clínica do Brasil	Brasilia	DF
Brazil	Sociedade Hospitalar Angelina Caron	Campina Grande Do Sul	Paraná
Brazil	Nucleo de Pesquisa Clinica Hospital do Rocio	Campo Largo	Paraná
Brazil	Centro Médico São Francisco	Curitiba	Paraná
Brazil	Hospital de Caridade de Ijuí	Ijuí	Rio Grande Do Sul
Brazil	Fundacao Doutor Amaral Carvalho	Jaú	São Paulo
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Mae de Deus	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade Da Santa Casa De Misericórdia De Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto De Medicina Integral Prof. Fernando Figueira - IMIP	Recife	Pernambuco
Brazil	Instituto Nacional de Cardiologia	Rio De Janeiro
Brazil	Fundação Faculdade Regional de Medicina de São José do Rio Preto	São José Do Rio Preto	São Paulo
Brazil	Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro	São Paulo
Brazil	Hospital Alemao Oswaldo Cruz	São Paulo
Brazil	Hospital Santa Marcelina	São Paulo
Brazil	Instituto D'Or de Pesquisa e Ensino	São Paulo
Brazil	Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor)	São Paulo
Brazil	Marina Leonardo	São Paulo
Brazil	Santa Casa de São Paulo (IPITEC)	São Paulo
Brazil	Universidade Federal do Triângulo Mineiro	Uberaba	Minas Gerais
Brazil	Integral Pesquisa e Ensino	Votuporanga	São Paulo
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Queen's University	Kingston	Ontario
Canada	Grand River Hospital, Grand River Regional Cancer Centre	Kitchener	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	London Health Sciences, Victoria Hospital	London	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	University Hospital of Montreal	Montreal	Quebec
Canada	Hopital Maisonneuve-Rosemont	Montréal	Quebec
Canada	McGill University	Montréal	Quebec
Canada	Niagara Health, St. Catharines Site	Niagara	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Laval University	Quebec City	Quebec
Canada	Centre Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Colombia	Hospital Universitario San Ignacio	Bogotá	Cundinamarca
Colombia	Fundacio Valle de Lili	Cali	Valle Del Cauca
Colombia	FOSCAL	Floridablanca	Santander
Israel	Heart Institute - Holon Medical Center	Holon
Israel	Rabin Medical Center	Petach Tikva
Israel	Tel-Aviv Sourasky Medical Centre	Tel Aviv
Turkey	Istanbul University	Istanbul
United States	Georgia Cancer Center at Augusta University	Augusta	Georgia
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Cancer Society (CCS), Prostate Cancer Canada

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Colombia,  Israel,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tertiary Efficacy Outcomes - Event Outcome - New or Worsening Angina	New or worsening angina.	3-5 years.
Other	Tertiary Efficacy Outcomes - Event Outcome - New Atrial Fibrillation	New atrial fibrillation.	3-5 years
Other	Tertiary Efficacy Outcomes - Cognitive Function	Cognitive function, as measured by the DSS test.	3-5 years
Other	Tertiary Efficacy Outcomes - Physical Measurement - Grip Strength	Handgrip strength, as measured using the JAMAR Dynamometer.	3-5 years
Other	Tertiary Efficacy Outcomes - Physical Measurement - Timed Walk Test	Timed-get-up-and-go-test.	3-5 years
Other	Tertiary Efficacy Outcomes - Physical Measurement - Walk Test	Six-minute walk distance.	3-5 years
Other	Tertiary Efficacy Outcomes - Physical Frailty	Physical Frailty	3-5 years
Other	Tertiary Efficacy Outcomes - Physical Measurement - Waist	Waist circumference.	3-5 years
Other	Tertiary Efficacy Outcomes - HbA1c	HbA1c concentration.	3-5 years
Other	Tertiary Efficacy Outcomes - Lipid Profile	Lipid profile.	3-5 years
Other	Tertiary Efficacy Outcomes - Event Outcome - Prostate Cancer Death	Prostate cancer death.	3-5 years
Other	Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PC Progression	Distant prostate cancer progression.	3-5 years
Other	Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Castrate-Resistant PC	Development of castrate-resistant prostate cancer	3-5 years
Other	Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - PSA Progression	PSA progression.	3-5 years
Other	Tertiary Efficacy Outcomes - Prostate Cancer Characteristics - Biochemical Failure	Biochemical failure.	3-5 years
Other	Safety Outcome - Emergent Adverse Event - Major Bleeding	Major bleeding.	3-5 years
Other	Safety Outcome - Emergent Adverse Event - Myositis	Myositis.	3-5 years
Other	Safety Outcome - Emergent Adverse Event - Liver Injury	Liver injury.	3-5 years
Other	Safety Outcome - Emergent Adverse Event - Kidney Injury	Kidney injury.	3-5 years
Primary	Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.	The primary efficacy outcome is the occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure, or arterial revascularization.	3-5 years
Secondary	Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.	The occurrence of the composite of all-cause mortality, myocardial infarction, stroke, or heart failure.	3-5 years
Secondary	Secondary Efficacy Outcome - Composite of Death, MI, Stroke	The composite of cardiovascular death, myocardial infarction, or stroke.	3-5 years
Secondary	Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.	The composite of cardiovascular death, myocardial infarction, stroke, heart failure, arterial revascularization, or unstable, new or worsening angina.	3-5 years
Secondary	Secondary Efficacy Outcome - Event Outcome - CV Death	Cardiovascular death.	3-5 years
Secondary	Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction	Myocardial infarction.	3-5 years
Secondary	Secondary Efficacy Outcome - Event Outcome - Stroke	Stroke.	3-5 years
Secondary	Secondary Efficacy Outcome - Event Outcome - Heart Failure	Heart failure.	3-5 years
Secondary	Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism	Venous Thromboembolism.	3-5 years