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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix (LHRH antagonist) | Experimental | Degarelix (LHRH antagonist) EndoPAT2000 |
|
| LHRH agonist | Active Comparator | LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix (LHRH antagonist) | Drug | Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, and twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in High sensitivity troponin (hsTn) value | High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury | Baseline, and after three, six and twelve months of treatment initiation |
| Change in C-reactive protein value |
| Measure | Description | Time Frame |
|---|---|---|
| Change in testosterone level | Baseline, and after three, six and twelve months of treatment initiation | |
| Change in gonadotropins levels | LH | Baseline, and after three, six and twelve months of treatment initiation |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| David Margel, MD, PhD | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 31096 | Israel | |||
| Rabin Medical Center - Beilinson Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34350976 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| LHRH agonist | Drug | LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year. |
|
|
| EndoPAT2000 | Device | Peripheral arterial plethysmography using an EndoPAT2000 device |
|
|
C-reactive protein is a biomarker for inflammation
| 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 | 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 | Baseline, and after three, six and twelve months of treatment initiation |
| Change in PSA value | Prostate-specific antigen | Baseline, and after three, six and twelve months of treatment initiation |
| Change in BMI | Body Mass Index | Baseline, and after three, six and twelve months of treatment initiation |
| Change in Quality Of Life score | As assessed by the FACT-P quality of life questionnaire | Baseline, and after three, six and twelve months of treatment initiation |
| Petah Tikva |
| 4941492 |
| Israel |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |