Investigation of association between clinically significant prostate cancer, obesity and platelet to-lymphocyte ratio and neutrophil -to-lymphocyte ratio.
Johanna Dahan, Jehonathan Pinthus, Guila Delouya...
https://pubmed.ncbi.nlm.nih.gov/39407194Actively Recruiting
Phase Not Applicable
Age: 45Years +
MALE
ID03127631
The Role of Androgen Deprivation Therapy in Cardiovascular Disease - A Longitudinal Prostate Cancer Study and a Randomized Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
Led by McMaster University · Updated on 2025-01-31
6000
Participants Needed
54
Research Sites
N/A
Total Duration
On this page
Sponsors
M
McMaster University
Lead Sponsor
P
Prostate Cancer Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating cardiovascular and lifestyle risk factors in men newly diagnosed with prostate cancer. The study includes RADICAL PC1, a prospective cohort study focusing on men diagnosed within a year or starting Androgen Deprivation Therapy recently, to identify factors linked to cardiovascular disease in this group. RADICAL PC2 is a randomized controlled trial within RADICAL PC1 that evaluates a systematic approach to modifying these risk factors. The intervention in RADICAL PC2 involves providing dietary and exercise advice, support to quit smoking if needed, and prescriptions of medications like statins and ACE inhibitors or other blood pressure medications when appropriate. The control group receives usual care, which may include referrals to specialists or treatments as decided by their doctors. The study observes participants over a period of 3 to 5 years. Participants will undergo regular assessments to monitor cardiovascular events such as death, heart attack, stroke, heart failure, and arterial revascularization. The study tracks these outcomes while monitoring adherence to lifestyle changes and medication use. The total participation involves ongoing follow-up for several years to understand the impact of interventions on cardiovascular health in men with prostate cancer.
CONDITIONS
Brief Title
A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
Who Can Participate
Age: 45Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male with a prostate cancer diagnosis made within 1 year of enrollment
- Treated with Androgen Deprivation Therapy for the first time within 6 months before enrollment, or planning to start it within 1 month after enrollment
- Age 45 years or older
You will not qualify if you...
- Unwilling to provide consent
- Younger than 45 years old
- Prostate cancer found incidentally after cystectomy for bladder cancer
- See a cardiologist every year
- Taking a statin and have systolic blood pressure of 130 mmHg or lower
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 to 5 years
Participants receive a systematic cardiovascular and lifestyle risk factor modification strategy, including dietary and exercise advice, advice to quit smoking, and prescriptions for statins and blood pressure medications as appropriate.
Regular visits scheduled as per study protocol
Trial Site Locations
Total: 54 locations
1
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
3
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
4
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
5
Flinders Medical Center
Adelaide, South Australia, Australia, 5042
Actively Recruiting
6
Centro de Pesquisa Clínica do Brasil
Brasília, Federal District, Brazil, 71625175
Actively Recruiting
7
Hospital Felício Rocho
Belo Horizonte, Minas Gerais, Brazil, 30110-934
Actively Recruiting
8
Universidade Federal do Triângulo Mineiro
Uberaba, Minas Gerais, Brazil, 38025-260
Actively Recruiting
9
Sociedade Hospitalar Angelina Caron
Campina Grande do Sul, Paraná, Brazil, 83.430-000
Actively Recruiting
10
Nucleo de Pesquisa Clinica Hospital do Rocio
Campo Largo, Paraná, Brazil
Actively Recruiting
11
Centro Médico São Francisco
Curitiba, Paraná, Brazil, 80810-050
Actively Recruiting
12
Instituto De Medicina Integral Prof. Fernando Figueira - IMIP
Recife, Pernambuco, Brazil, 50.070-902
Actively Recruiting
13
Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro, Brazil, 22240-006
Actively Recruiting
14
Hospital de Caridade de Ijuí
Ijuí, Rio Grande do Sul, Brazil, 98700-000
Actively Recruiting
15
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
16
Irmandade Da Santa Casa De Misericórdia De Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
Actively Recruiting
17
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil, 90840-440
Actively Recruiting
18
Hospital Municipal de Barueri
Barueri, São Paulo, Brazil, 06463-320
Actively Recruiting
19
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
Botucatu, São Paulo, Brazil, 18618-687
Actively Recruiting
20
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo, Brazil, 12.916-542
Actively Recruiting
21
Fundacao Doutor Amaral Carvalho
Jaú, São Paulo, Brazil, 17210080
Actively Recruiting
22
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
23
Santa Casa de São Paulo (IPITEC)
São Paulo, São Paulo, Brazil, 01223-001
Actively Recruiting
24
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil, 01327001
Actively Recruiting
25
Beneficência Nipo-Brasileira de São Paulo. Hospital Nipo-Brasileiro
São Paulo, São Paulo, Brazil, 02189-000
Actively Recruiting
26
Marina Leonardo
São Paulo, São Paulo, Brazil, 04014-002
Actively Recruiting
27
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Fundação Zerbini (Incor)
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
28
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil, 08270-120
Actively Recruiting
29
Instituto D'Or de Pesquisa e Ensino
São Paulo, São Paulo, Brazil, 4543000
Actively Recruiting
30
Integral Pesquisa e Ensino
Votuporanga, São Paulo, Brazil, 15501-405
Actively Recruiting
31
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
32
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N4A6
Actively Recruiting
33
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V1C3
Actively Recruiting
34
Queen's University
Kingston, Ontario, Canada, K7L 3J7
Actively Recruiting
35
Grand River Hospital, Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3
Actively Recruiting
36
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
37
London Health Sciences, Victoria Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
38
Niagara Health, St. Catharines Site
Niagara, Ontario, Canada, L2S 0A9
Actively Recruiting
39
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
40
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
41
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Active, Not Recruiting
42
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
43
University Hospital of Montreal
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
44
McGill University
Montreal, Quebec, Canada, H3A 0G4
Actively Recruiting
45
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
46
Laval University
Québec, Quebec, Canada, G1V 0A6
Actively Recruiting
47
Centre Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
48
Hospital Universitario San Ignacio
Bogotá, Cundinamarca, Colombia
Not Yet Recruiting
49
FOSCAL
Floridablanca, Santander Department, Colombia
Actively Recruiting
50
Fundacio Valle de Lili
Cali, Valle del Cauca Department, Colombia
Actively Recruiting
51
Heart Institute - Holon Medical Center
Holon, Israel, 5840608
Actively Recruiting
52
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
53
Tel-Aviv Sourasky Medical Centre
Tel Aviv, Israel, 6423906
Actively Recruiting
54
Istanbul University
Istanbul, Turkey (Türkiye)
Terminated
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Research Team
S
Sarah Karampatos, BASc, MSc
S
Steven Agapay, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
Nevena Savija, Darryl P Leong, Jehonathan Pinthus...
https://pubmed.ncbi.nlm.nih.gov/34870071