Clinical trial · Interventional
Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists
A Pilot Study on Endothelial Function and Cardiovascular Biomarkers in Prostate Cancer (PCa) Patients, With Pre-existing Cardiovascular Disease, Treated With Degarelix vs. Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
NCT02475057CI-TRIAL-00039042completedPhase 4ClinicalTrials.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)
The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix (LHRH antagonist) | Drug | Degarelix | ALIAS |
| EndoPAT2000 | Device | — | UNRESOLVED |
| LHRH agonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Degarelix (LHRH antagonist)
- description
- Degarelix (LHRH antagonist) EndoPAT2000
- interventionNames
- Drug: Degarelix (LHRH antagonist)
- Device: EndoPAT2000
- type
- ACTIVE_COMPARATOR
- label
- LHRH agonist
- description
- LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000
- interventionNames
- Drug: LHRH agonist
- Device: EndoPAT2000
Primary outcomes (1)
- measure
- Change in Reactive Hyperemia Index from baseline to twelve months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer. * Scheduled to start ADT for a period of at least one year. * Subject has a history of one or more of the following: 1. Myocardial infarction 2. Ischaemic or Haemorrhagic cerebrovascular conditions 3. Arterial embolic and thrombotic events, 4. Ischaemic heart disease 5. Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures) 6. Peripheral vascular disease (e.g. significant stenosis (ABPI\<0.9), claudication, prior vascular surgery/intervention) * Life expectancy of over 12 months. * WHO performance status of 0-2 * Subject is able and has agreed to sign a consent form. Exclusion Criteria: * Prior use of ADT. However, prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat will be allowed. * Prior use of dutasteride/finasteride in past 6 months * Known allergic reaction to Degarelix. * Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
References
Publications (1)
- DERIVEDZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976