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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
McMaster University
Study ID
NCT03127631
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nutrition — BEHAVIORAL
    Standardized advice on healthy diet practices.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 21, 2015
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
6,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc. [ Time Frame: 3-5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912
Hyma Kunhiraman Harikrishnan
[email protected]
Avirup Guha (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Terry Christenson
[email protected]
Charles Porter (PRINCIPAL_INVESTIGATOR)

Find similar trials in Augusta, GA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Georgia Cancer Center at Augusta University· Augusta, GAUniversity of Kansas Medical Center· Kansas City, KS

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