Status:
COMPLETED
Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
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 cl...
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 re...
Eligibility Criteria
Inclusion
- Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
- Eligible cohort entry dates:
- The degarelix indication for treatment of prostate cancer was approved by the FDA on Dec 24, 2008. Leuprolide was initially approved for the same indication prior to Dec 24, 2008.
- IBM MarketScan: Dec 24, 2008 - December 31, 2018 (end of available data) Optum CDM: Dec 24, 2008 - June 30, 2020 (end of available data) CMS Diabetes: Dec 24, 2008 - Dec 31, 2017 (end of available data)
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
14417 Patients enrolled
Trial Details
Trial ID
NCT04897958
Start Date
September 21 2019
End Date
August 1 2021
Last Update
July 27 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120