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:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02475057
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02475057
Study Brief:
Protocol Section:
NCT02475057