Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data
- Registration Number
- NCT04897958
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
- Detailed Description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14417
- Histologically confirmed adenocarcinoma of the prostate
- Pre-existing ASCVD (confirmed diagnosis, documented) according to a least 1 of the following criteria:
- Previous MI >= 30 days before randomization
- Previous revascularization procedure >= 30 days before randomization
- Coronary artery: stent placement/balloon angioplasty or coronary artery bypass graft surgery
- Carotid artery: stent placement/balloon angioplasty or endarterectomy surgery
- Iliac, femoral, popliteal arteries: stent placement/balloon angioplasty or vascular bypass surgery
- Treatment naivety (ADT)
- Previous or current hormonal management of prostate cancer including surgical castration, any hormonal manipulation, or any previous neoadjuvant/adjuvant hormonal therapy, unless treatment was terminated more than 12 months prior to enrollment
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Uncontrolled hypertension
- A history of congenital long QT syndrome or risk factors for Torsade de pointes ventricular arrhythmias
- MI; stroke; or coronary, carotid, or peripheral artery revascularization
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Degarelix Degarelix Reference group Leuprolide Leuprolide Exposure group
- Primary Outcome Measures
Name Time Method Major Adverse Cardiovascular Events (MACE) Through study completion (earliest of 336 days or censoring) Composite of all-cause mortality, nonfatal MI, and nonfatal stroke
- Secondary Outcome Measures
Name Time Method Nonfatal MI Through study completion (earliest of 336 days or censoring) Component of MACE
All-Cause Mortality Through study completion (earliest of 336 days or censoring) Component of MACE
Nonfatal Stroke Through study completion (earliest of 336 days or censoring) Component of MACE
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States