Clinical trial · Interventional
A Study for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients
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)
NCT03127631CI-TRIAL-00116595RADICALPCactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Disease | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACE inhibitor | Drug | — | UNRESOLVED |
| Exercise | Behavioral | — | UNRESOLVED |
| Nutrition | Behavioral | — | UNRESOLVED |
| Smoking cessation | Behavioral | — | UNRESOLVED |
| Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Randomized - Intervention
- description
- 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.
- interventionNames
- Behavioral: Nutrition
- Behavioral: Exercise
- Behavioral: Smoking cessation
- Drug: Statin (such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
- Drug: ACE inhibitor
- type
- NO_INTERVENTION
- label
- Randomized - Control
- description
- 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 outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDLeong DP, Higano C, Cano Garcia C, Fradet V, Siemens DR, Niazi T, Shayegan B, Guha A, Cirne F, Selvanayagam JB, Violette PD, Valle FH, Lavallee LT, Duceppe E, Anderson P, Xavier D, Lopez-Lopez JP, Villareal Trujillo N, Galapo Kann A, Piccoli RK, Mourtzakis M, Sarid D, Narasimha S, Luke PPW, Hajjar LA, Lukka H, Klotz L, Balasubramanian K, Mian R, Agapay S, Rangarajan S, Karampatos S, Ng KKH, Avezum A, Devereaux PJ, Pinthus JH; RADICAL PC Investigators. Specialist Referral for Cardiovascular Risk in Patients With Prostate Cancer: A Randomized Clinical Trial. JAMA Intern Med. 2026 Aug 30. doi: 10.1001/jamainternmed.2026.4773. Online ahead of print. PMID 42669035
- DERIVEDDahan 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. PMID 39407194
- DERIVEDSavija 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. PMID 34870071