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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04182594
Eligibility 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04182594
Study Brief:
Protocol Section:
NCT04182594