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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).
To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix | Experimental | Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 50% fall in PSA | Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist | 8 weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Luteinizing hormone (LH) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| Follicle stimulating hormone (FSH) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim N Chi, MD | Contact | +1 604 877 6000 | 2746 | kim.chi@bccancer.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kim N Chi, MD | British Columbia Cancer Agency, Univeristy of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z4E6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21788033 | Result | Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schroder F, Shore N, Moul JW, Jensen JK, Olesen TK, Persson BE. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol. 2011 Sep;186(3):889-97. doi: 10.1016/j.juro.2011.04.083. Epub 2011 Jul 23. |
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| 8 weekly |
| Testosterone (TT) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dehydroepiandrosterone (DHEA) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dehydroepiandrosterone-sulfate (DHEA-S) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| androstenedione (AED) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| dihydrotestosterone (DHT) | Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly). | 8 weekly |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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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 |
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