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| Name | Class |
|---|---|
| Prostate Cancer Canada | OTHER |
| Canadian Cancer Society (CCS) | OTHER |
| Tolmar Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized - Intervention | Active Comparator | The intervention will consist of a systematic cardiovascular and lifestyle risk factor modification strategy, including dietary and exercise advice, advice to quit smoking, and the prescription of open-label statins, ACE-I, and other antihypertensive medications where appropriate. |
|
| Randomized - Control | No Intervention | The control will consist of usual clinical care, which may include a referral to a cardiologist or internist, or the use of treatments included in the intervention as clinically indicated, if part of the treating physician's standard practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition | Behavioral | Standardized advice on healthy diet practices. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure. | Time to the first occurrence of the composite of cardiovascular death, myocardial infarction, stroke, heart failure. | 3-5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Analyses Endpoint - Systolic Blood Pressure | Measure of systolic blood pressure | 3-5 years |
| Exploratory Analyses Endpoint - Total and Low-Density Lipoprotein Cholesterol | Measure of total and low-density lipoprotein cholesterol |
Inclusion Criteria:
1. A man with a diagnosis of prostate cancer that is either:
Exclusion Criteria:
Patients will be excluded if they fulfill any of the following:
Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC | McMaster University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | United States | ||
| University of Kansas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39407194 | Derived | Dahan J, Pinthus J, Delouya G, Taussky D, Duceppe E, de Jesus A, Leong D. Investigation of association between clinically significant prostate cancer, obesity and platelet to-lymphocyte ratio and neutrophil -to-lymphocyte ratio. BMC Urol. 2024 Oct 16;24(1):226. doi: 10.1186/s12894-024-01617-2. | |
| 34870071 | Derived |
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| 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. |
|
| 3-5 years |
| Exploratory Analyses Endpoint - Hemoglobin A1c Concentration | Hemoglobin A1c concentration | 3-5 years |
| Exploratory Analyses Endpoint - Handgrip Strength | Measure of handgrip strength | 3-5 years |
| Exploratory Analyses Endpoint - Get-Up-and-Go Time | Timed get-up-and-go test | 3-5 years |
| Exploratory Analyses Endpoint - Waist Circumference | Measure of waist circumference | 3-5 years |
| Exploratory Analyses Endpoint - Six-Minute Walk Distance | Distance walked in six minutes | 3-5 years |
| Exploratory Analyses Endpoint - Digital Symbol Substitution (DSS) Test | Digital symbol substitution (DSS) test score | 3-5 years |
| Safety Outcome - Emergent Adverse Event - Major Bleeding | Major bleeding. | 3-5 years |
| Safety Outcome - Emergent Adverse Event - Myositis | Myositis. | 3-5 years |
| Safety Outcome - Emergent Adverse Event - Liver Injury | Liver injury. | 3-5 years |
| Safety Outcome - Emergent Adverse Event - Kidney Injury | Kidney injury. | 3-5 years |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Center | Adelaide | South Australia | 5042 | Australia |
| Centro de Pesquisa Clínica do Brasil | Brasília | Federal District | 71625175 | Brazil |
| Hospital Felício Rocho | Belo Horizonte | Minas Gerais | 30110-934 | Brazil |
| Universidade Federal do Triângulo Mineiro | Uberaba | Minas Gerais | 38025-260 | Brazil |
| Sociedade Hospitalar Angelina Caron | Campina Grande do Sul | Paraná | 83.430-000 | Brazil |
| Nucleo de Pesquisa Clinica Hospital do Rocio | Campo Largo | Paraná | Brazil |
| Centro Médico São Francisco | Curitiba | Paraná | 80810-050 | Brazil |
| Instituto De Medicina Integral Prof. Fernando Figueira - IMIP | Recife | Pernambuco | 50.070-902 | Brazil |
| Instituto Nacional de Cardiologia | Rio de Janeiro | Rio de Janeiro | 22240-006 | Brazil |
| Hospital de Caridade de Ijuí | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Irmandade Da Santa Casa De Misericórdia De Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Hospital Mae de Deus | Porto Alegre | Rio Grande do Sul | 90840-440 | Brazil |
| Hospital Municipal de Barueri | Barueri | São Paulo | 06463-320 | Brazil |
| Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP | Botucatu | São Paulo | 18618-687 | Brazil |
| Hospital Universitário São Francisco na Providência de Deus | Bragança Paulista | São Paulo | 12.916-542 | Brazil |
| Fundacao Doutor Amaral Carvalho | Jaú | São Paulo | 17210080 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Santa Casa de São Paulo (IPITEC) | São Paulo | São Paulo | 01223-001 | Brazil |
| Hospital Alemao Oswaldo Cruz | São Paulo | São Paulo | 01327001 | Brazil |
| Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro | São Paulo | São Paulo | 02189-000 | Brazil |
| Núcleo de Pesquisa e Ensino da Rede São Camilo | São Paulo | São Paulo | 04014-002 | Brazil |
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor) | São Paulo | São Paulo | 05403-000 | Brazil |
| Hospital Santa Marcelina | São Paulo | São Paulo | 08270-120 | Brazil |
| Instituto D'Or de Pesquisa e Ensino | São Paulo | São Paulo | 4543000 | Brazil |
| Integral Pesquisa e Ensino | Votuporanga | São Paulo | 15501-405 | Brazil |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | L8N4A6 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V1C3 | Canada |
| Queen's University | Kingston | Ontario | K7L 3J7 | Canada |
| Grand River Hospital, Grand River Regional Cancer Centre | Kitchener | Ontario | N2G 1G3 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| London Health Sciences, Victoria Hospital | London | Ontario | N6A 5W9 | Canada |
| Niagara Health, St. Catharines Site | Niagara | Ontario | L2S 0A9 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network, Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2C1 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| University Hospital of Montreal | Montreal | Quebec | H2X 0A9 | Canada |
| McGill University | Montreal | Quebec | H3A 0G4 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Laval University | Québec | Quebec | G1V 0A6 | Canada |
| Centre Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Hospital Universitario San Ignacio | Bogotá | Cundinamarca | Colombia |
| FOSCAL | Floridablanca | Santander Department | Colombia |
| Fundacio Valle de Lili | Cali | Valle del Cauca Department | Colombia |
| Sri Ram Cancer & Superspeciality Centre, Mahatma Gandhi Hospital | Sītāpura | Jaipur | 302022 | India |
| Sri shanakara cancer Hospital and Research Centre | Bengaluru | Kamataka | 560004 | India |
| St. John's Medical College and Hospital | Bangalore | Karntaka | 560034 | India |
| Kamineni Academy of Medical Sciences and Research Centre | Hyderabad | Telangana | 500068 | India |
| Heart Institute - Holon Medical Center | Holon | 5840608 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| Tel-Aviv Sourasky Medical Centre | Tel Aviv | 6423906 | Israel |
| National University Hospital | Singapore | Singapore | 119228 | Singapore |
| Istanbul University | Istanbul | Turkey (Türkiye) |
| Savija N, Leong DP, Pinthus J, Karampatos S, Shayegan B, Mian R, Rangarajan S, Fradet V, de Souza RJ, Mente A, Dehghan M. 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. Curr Dev Nutr. 2021 Aug 12;5(11):nzab106. doi: 10.1093/cdn/nzab106. eCollection 2021 Nov. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D015444 | Exercise |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D019821 | Simvastatin |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| D017035 | Pravastatin |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D011480 | Protease Inhibitors |
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