Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14417 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-21

Study Completion Date

2021-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Degarelix

Reference group

Degarelix

Intervention Type DRUG

Degarelix dispensing claim is used as the reference group.

Leuprolide

Exposure group

Leuprolide

Intervention Type DRUG

Leuprolide dispensing claim is used as the exposure group.

Interventions

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Degarelix

Degarelix dispensing claim is used as the reference group.

Intervention Type DRUG

Leuprolide

Leuprolide dispensing claim is used as the exposure group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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 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

Eligible Sex

MALE

Accepts Healthy Volunteers

No