Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT04897958
Eligibility Criteria:
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
Sex:
MALE
Study:
NCT04897958
Study Brief:
Protocol Section:
NCT04897958