Prostatic NeoplasmsPhase 4NCT02475057
Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists
A Phase 4 study testing Degarelix (LHRH antagonist), LHRH agonist and EndoPAT2000 in people with Prostatic Neoplasms and Cardiovascular Diseases, run by Rabin Medical Center at 2 sites in Israel.
Trial summary
The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Cardiovascular Diseases
- What is being tested?
- Degarelix (LHRH antagonist), LHRH agonist and EndoPAT2000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2015to Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Myocardial infarction
- Ischaemic or Haemorrhagic cerebrovascular conditions
- Arterial embolic and thrombotic events,
Show all 12Show fewer
- Ischaemic heart disease
- Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rambam Health Care Campus
Haifa, 31096
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492
About this study
Official 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
The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.
Read the detailed description
This is a national multicenter randomized open-label superiority study of the use of Degarelix compared to LHRH agonists among men with advanced prostate cancer and pre-existing cardiovascular disease. Patients will be stratified based on baseline endothelial function and presence prostate cancer metastasis.
Study population: Subjects with pre-existing cardiovascular disease with locally advanced or metastatic prostate cancer and scheduled to start Androgen Deprivation Therapy (ADT). Patients already on ADT will be excluded. subjects will receive either two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months or an LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year. Follow-up visits will occur every 3 months. A blood sample for Prostate-specific antigen (PSA), cardiac biomarkers and rectal examination will be performed each visit. At baseline 6 and 12 months EndoPAT2000 measurements will be taken.
- Conditions
- Prostatic Neoplasms, Cardiovascular Diseases
- Being tested
- Degarelix (LHRH antagonist), LHRH agonist, EndoPAT2000
- Keywords
- Prostate Cancer, Cardiovascular disease, Degarelix
- Medical subject headings
- Prostatic Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degarelix (LHRH antagonist)Drug
Also called Firmagon
Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.
LHRH agonistDrug
Also called Luteinizing hormone-releasing hormone agonist
LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.
EndoPAT2000Device
Also called Peripheral arterial plethysmography
Peripheral arterial plethysmography using an EndoPAT2000 device
| Study group | Role | What they receive |
|---|---|---|
| Degarelix (LHRH antagonist) | Experimental | Degarelix (LHRH antagonist) EndoPAT2000 Receives: Drug: Degarelix (LHRH antagonist); Device: EndoPAT2000 |
| LHRH agonist | Active comparator | LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000 Receives: Drug: LHRH agonist; Device: EndoPAT2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Reactive Hyperemia Index from baseline to twelve months
the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000
Measured: Baseline, and twelve months
Secondary outcomes (4)
Change in High sensitivity troponin (hsTn) value
High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury
Measured: Baseline, and after three, six and twelve months of treatment initiation
Change in C-reactive protein value
C-reactive protein is a biomarker for inflammation
Measured: Baseline, and after three, six and twelve months of treatment initiation
Change in D-dimer value
D-dimer is a biomarker for coagulation system activation
Measured: Baseline, and after three, six and twelve months of treatment initiation
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value
N-terminal pro-brain natriuretic peptide (NT-proBNP) is a biomarker for myocardial strain
Measured: Baseline, and after three, six and twelve months of treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- David Margel, MD, PhD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475057
- Sponsor's protocol ID
- 0102-15-RMC
- Status last verified
- Jun 2019
- First submitted
- 8 Jun 2015
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zengerling 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.
PubMed 34350976
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02475057
- Acronym / sponsor ID
- 0102-15-RMC
- Conditions
- Prostatic Neoplasms, Cardiovascular Diseases
- Keywords
- Prostate Cancer, Cardiovascular disease, Degarelix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.
Detailed description
This is a national multicenter randomized open-label superiority study of the use of Degarelix compared to LHRH agonists among men with advanced prostate cancer and pre-existing cardiovascular disease. Patients will be stratified based on baseline endothelial function and presence prostate cancer metastasis.
Study population: Subjects with pre-existing cardiovascular disease with locally advanced or metastatic prostate cancer and scheduled to start Androgen Deprivation Therapy (ADT). Patients already on ADT will be excluded. subjects will receive either two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months or an LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year. Follow-up visits will occur every 3 months. A blood sample for Prostate-specific antigen (PSA), cardiac biomarkers and rectal examination will be performed each visit. At baseline 6 and 12 months EndoPAT2000 measurements will be taken.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degarelix (LHRH antagonist) | Experimental | Drug: Degarelix (LHRH antagonist), Device: EndoPAT2000Degarelix (LHRH antagonist) EndoPAT2000 |
| LHRH agonist | Active comparator | Drug: LHRH agonist, Device: EndoPAT2000LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Life expectancy of over 12 months.
- WHO performance status of 0-2
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Degarelix (LHRH antagonist)Also: FirmagonTwo initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months. | Drug | Degarelix (LHRH antagonist) |
| LHRH agonistAlso: Luteinizing hormone-releasing hormone agonistLHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year. | Drug | LHRH agonist |
| EndoPAT2000Also: Peripheral arterial plethysmographyPeripheral arterial plethysmography using an EndoPAT2000 device | Device | Degarelix (LHRH antagonist), LHRH agonist |
Primary outcome
Change in Reactive Hyperemia Index from baseline to twelve months
Time frame: Baseline, and twelve months
the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000
4 secondary outcomes
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 D-dimer 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Derived from this study: PubMed 34350976Zengerling 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Margel, MD, PhD principal investigator
Rabin Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Degarelix (LHRH antagonist), LHRH agonist and EndoPAT2000 in people with Prostatic Neoplasms and Cardiovascular Diseases, run by Rabin Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reactive Hyperemia Index from baseline to twelve months (time frame: Baseline, and twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.