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Replication of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04897958
Collaborator
(none)
14,417
Enrollment
1
Location
36
Anticipated Duration (Months)
400.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Actual Enrollment :
14417 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Replication of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data
Actual Study Start Date :
Sep 21, 2019
Anticipated Primary Completion Date :
Sep 21, 2022
Anticipated Study Completion Date :
Sep 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Degarelix

Reference group

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

Exposure group

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. All-Cause Mortality [Through study completion (earliest of 336 days or censoring)]

    Component of MACE

  2. Nonfatal MI [Through study completion (earliest of 336 days or censoring)]

    Component of MACE

  3. Nonfatal Stroke [Through study completion (earliest of 336 days or censoring)]

    Component of MACE

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02120

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

  • Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jessica Franklin, Visiting Scientist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04897958
Other Study ID Numbers:
  • DUPLICATE-PRONOUNCE
First Posted:
May 24, 2021
Last Update Posted:
May 24, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Prostatic Neoplasms
Leuprolide

Study Results

No Results Posted as of May 24, 2021