Cardiovascular Events in GnRH Agonist vs. Antagonist

• Status: Not yet recruiting
• Trial end date: 2023-01-17
• Target enrollment: 0
• Participant gender: Male

Summary

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?

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Collaborator: Ferring Pharmaceuticals
• Treatments: Deslorelin; Triptorelin Pamoate

Criteria

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.