Clinical trial · Interventional
Cardiovascular Events in GnRH Agonist vs. Antagonist
A Phase-II, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Cardiovascular Events in Patients With Prostate Cancer and Cardiovascular Risk Factors Receiving Degarelix or GnRH Agonist
- 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 if the use of Degarelix for 1 year associated with a lower rate of cardiovascular toxicity compared to Gonadotropin-releasing hormone (GnRH) agonists in patients with advanced prostate cancer and cardiovascular risk factors, receiving combination therapy of Androgen deprivation therapy (ADT) and second line hormonal or chemotherapy?
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Event | — | UNRESOLVED | — |
| Hormone Sensitive Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
| GnRH agonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Degarelix
- description
- GnRH Antagonist
- interventionNames
- Drug: Degarelix
- type
- ACTIVE_COMPARATOR
- label
- GnRH-agonist
- description
- GnRH Agonist
- interventionNames
- Drug: GnRH agonist
Primary outcomes (1)
- measure
- time to first cardiovascular event
- timeFrame
- 1 year
- description
- To compare time to first cardiovascular event as estimated by the cumulated probability at the 1-year time-point of patients with advanced prostate cancer treated for one year with Degarelix vs. GnRH agonist. This will be a composite outcome composed of: Death, CVA, MI, TIA, cardiac emergency room visits, heart catheterization.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Locally advanced high-risk prostate cancer OR metastatic prostate cancer patients. 2. Patients are scheduled to receive a combination of either 1. primary ADT for 12 months + either chemotherapy with docetaxel OR 2. primary ADT for 12 months + second line hormonal treatment with abiraterone/ enzalutamide/ apalutamide 3. Patients with a medical history of either 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( 7. Two out of three cardiovascular risk factors: hypertension, diabetes, current smoking. 4. Patients age 18-90 years. 5. Life expectancy of over 12 months. 6. WHO performance status of 0-2 7. Subject is able and has agreed to sign a consent form. Exclusion Criteria: 1. Prior use of ADT in past 6 months prior to randomization. We will, however, allow prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat. 2. Known allergic reaction to Degarelix. 3. 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