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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03127631




Registration number
NCT03127631
Ethics application status
Date submitted
7/09/2016
Date registered
25/04/2017

Titles & IDs
Public title
A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
Scientific 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)
Secondary ID [1] 0 0
RADICALPC_009-001
Universal Trial Number (UTN)
Trial acronym
RADICALPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Nutrition
BEHAVIORAL - Exercise
BEHAVIORAL - Smoking cessation
Treatment: Drugs - Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
Treatment: Drugs - ACE inhibitor

Active comparator: Randomized - Intervention - 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.

No intervention: Randomized - Control - 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.


BEHAVIORAL: Nutrition
Standardized advice on healthy diet practices.

BEHAVIORAL: Exercise
Standardized advice on exercise including strength training and resistance training exercises.

BEHAVIORAL: Smoking cessation
Advice to quit smoking, if applicable, and on available aids to quit smoking,

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
Timepoint [1] 0 0
3-5 years
Secondary outcome [1] 0 0
Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
Timepoint [1] 0 0
3-5 years
Secondary outcome [2] 0 0
Secondary Efficacy Outcome - Composite of Death, MI, Stroke
Timepoint [2] 0 0
3-5 years
Secondary outcome [3] 0 0
Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
Timepoint [3] 0 0
3-5 years
Secondary outcome [4] 0 0
Secondary Efficacy Outcome - Event Outcome - CV Death
Timepoint [4] 0 0
3-5 years
Secondary outcome [5] 0 0
Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
Timepoint [5] 0 0
3-5 years
Secondary outcome [6] 0 0
Secondary Efficacy Outcome - Event Outcome - Stroke
Timepoint [6] 0 0
3-5 years
Secondary outcome [7] 0 0
Secondary Efficacy Outcome - Event Outcome - Heart Failure
Timepoint [7] 0 0
3-5 years
Secondary outcome [8] 0 0
Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism
Timepoint [8] 0 0
3-5 years

Eligibility
Key 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
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
Brazil
State/province [3] 0 0
DF
Country [4] 0 0
Brazil
State/province [4] 0 0
Minas Gerais
Country [5] 0 0
Brazil
State/province [5] 0 0
Paraná
Country [6] 0 0
Brazil
State/province [6] 0 0
Pernambuco
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio Grande Do Sul
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio De Janeiro
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Colombia
State/province [13] 0 0
Cundinamarca
Country [14] 0 0
Colombia
State/province [14] 0 0
Santander
Country [15] 0 0
Colombia
State/province [15] 0 0
Valle Del Cauca
Country [16] 0 0
Israel
State/province [16] 0 0
Holon
Country [17] 0 0
Israel
State/province [17] 0 0
Petach Tikva
Country [18] 0 0
Israel
State/province [18] 0 0
Tel Aviv
Country [19] 0 0
Turkey
State/province [19] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Prostate Cancer Canada
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Cancer Society (CCS)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Karampatos, BASc, MSc
Address 0 0
Country 0 0
Phone 0 0
905-527-4322
Fax 0 0
Email 0 0
sarah.karampatos@phri.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03127631