Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data

Prostate Cancer Clinical Trial

Official title:

Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897958
• Other study ID #: 2018P002966-DUP-PRONOUNCE
• Status: Completed
• Start date: September 21, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 14417
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Degarelix dispensing claim is used as the reference group.
• Leuprolide
Leuprolide dispensing claim is used as the exposure group.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events (MACE)	Composite of all-cause mortality, nonfatal MI, and nonfatal stroke	Through study completion (earliest of 336 days or censoring)
Secondary	All-Cause Mortality	Component of MACE	Through study completion (earliest of 336 days or censoring)
Secondary	Nonfatal MI	Component of MACE	Through study completion (earliest of 336 days or censoring)
Secondary	Nonfatal Stroke	Component of MACE	Through study completion (earliest of 336 days or censoring)