Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
How are testosterone levels of patients with prostate cancer under treatment with Firmagon® changing.
Former studies showed a quick fall of testosterone levels after start of therapy with Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this in a normal outpatient urologist setting. Furthermore data is collected to prove the adherence to the German S3-Guideline for the treatment of prostate cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix | adult male patients with advanced hormone dependent prostate cancer who receive 240 mg as a start dose and then monthly 80mg Firmagon® for one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | subcutaneous injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PSA-/Testosterone Level | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| S3 Guideline | Percentage of patients who have been treated in accordance with the grade A recommendations of the S3 guideline for treatment of prostate cancer | 12 months |
| Anxiety | Anxiety score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
adult male patients of outpatient urological medical practice
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leopold Durner, MD | UCM GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCM GmbH | Planegg | Bavaria | 82152 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2122011 | Background | Thompson IM, Zeidman EJ, Rodriguez FR. Sudden death due to disease flare with luteinizing hormone-releasing hormone agonist therapy for carcinoma of the prostate. J Urol. 1990 Dec;144(6):1479-80. doi: 10.1016/s0022-5347(17)39774-4. | |
| 19035858 | Background | Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 Months |
| 17698136 | Background | Morote J, Orsola A, Planas J, Trilla E, Raventos CX, Cecchini L, Catalan R. Redefining clinically significant castration levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007 Oct;178(4 Pt 1):1290-5. doi: 10.1016/j.juro.2007.05.129. Epub 2007 Aug 14. |
| 19747358 | Background | Perachino M, Cavalli V, Bravi F. Testosterone levels in patients with metastatic prostate cancer treated with luteinizing hormone-releasing hormone therapy: prognostic significance? BJU Int. 2010 Mar;105(5):648-51. doi: 10.1111/j.1464-410X.2009.08814.x. Epub 2009 Aug 28. |
| 16697805 | Background | Mariani S, Salvatori L, Basciani S, Arizzi M, Franco G, Petrangeli E, Spera G, Gnessi L. Expression and cellular localization of follicle-stimulating hormone receptor in normal human prostate, benign prostatic hyperplasia and prostate cancer. J Urol. 2006 Jun;175(6):2072-7; discussion 2077. doi: 10.1016/S0022-5347(06)00273-4. |
| 20961245 | Background | Radu A, Pichon C, Camparo P, Antoine M, Allory Y, Couvelard A, Fromont G, Hai MT, Ghinea N. Expression of follicle-stimulating hormone receptor in tumor blood vessels. N Engl J Med. 2010 Oct 21;363(17):1621-30. doi: 10.1056/NEJMoa1001283. |
| Background | Heidenreich A., Epplen R., Thüer D., Van Erps T., D.P., EURO Prostate Center. EAU guideline on advanced prostate cancer: Compliance among urologists conderning androgen deprivation therapy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |