Clinical trial · Observational
Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data
NCT04897958CI-TRIAL-00068335completedClinicalTrials.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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
| Leuprolide | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Degarelix
- description
- Reference group
- interventionNames
- Drug: Degarelix
- label
- Leuprolide
- description
- Exposure group
- interventionNames
- Drug: Leuprolide
Primary outcomes (1)
- measure
- Major Adverse Cardiovascular Events (MACE)
- timeFrame
- Through study completion (earliest of 336 days or censoring)
- description
- Composite of all-cause mortality, nonfatal MI, and nonfatal stroke
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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) Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.