|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02475057 |
|
Date of registration:
|
08/06/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists
|
|
Scientific title:
|
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 |
|
Date of first enrolment:
|
August 2015 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02475057 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
David Margel, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rabin Medical Center |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Prostatic Neoplasms
|
|
Cardiovascular Diseases
|
|
Intervention(s)
|
|
Device: EndoPAT2000
|
|
Drug: Degarelix (LHRH antagonist)
|
|
Drug: LHRH agonist
|
|
Primary Outcome(s)
|
|
Change in Reactive Hyperemia Index from baseline to twelve months
[Time Frame: Baseline, and twelve months]
|
|
Secondary Outcome(s)
|
|
Change in D-dimer value
[Time Frame: Baseline, and after three, six and twelve months of treatment initiation]
|
|
Change in High sensitivity troponin (hsTn) value
[Time Frame: Baseline, and after three, six and twelve months of treatment initiation]
|
|
Change in C-reactive protein value
[Time Frame: Baseline, and after three, six and twelve months of treatment initiation]
|
|
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value
[Time Frame: Baseline, and after three, six and twelve months of treatment initiation]
|
|
Secondary ID(s)
|
|
0102-15-RMC
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|