Testosterone suppression with a unique form of leuprorelin acetate as a solid biodegradable implant in patients with advanced prostate cancer: results from four trials and comparison with the traditional leuprorelin acetate microspheres formulation
| Autor: | Davide Meani, Anders Bjartell, Mladen Solarić, Ursula Thyroff-Friesinger |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Urology 030232 urology & nephrology lcsh:RC870-923 03 medical and health sciences chemistry.chemical_compound Prostate cancer 0302 clinical medicine Leuprorelin medicine In patient Testosterone Original Research Gynecology business.industry Biodegradable implants lcsh:Diseases of the genitourinary system. Urology medicine.disease humanities Clinical trial Castration chemistry 030220 oncology & carcinogenesis Implant Corrigendum business medicine.drug |
| Zdroj: | Therapeutic Advances in Urology, Vol 9 (2017) |
| ISSN: | 1756-2880 1756-2872 |
| Popis: | Background: There are two slow-release ready-to-use forms of leuprorelin acetate (1-month and 3-month) that are available as solid, biodegradable implants for the treatment of advanced, hormone-sensitive prostate cancer. These implants have been shown to be as effective as traditional leuprorelin acetate microspheres for achieving successful testosterone suppression (⩽0.5 ng/ml) and lowering prostate-specific antigen (PSA) levels. Here we further evaluate testosterone suppression levels from four clinical trials evaluating the 3-month leuprorelin implant, including analysis below the European Association of Urology (EAU) castration level (Methods: Studies were conducted in patients with locally advanced/metastatic prostate cancer: (1) a randomised, controlled single-dose study comparing the leuprorelin implant with leuprorelin microspheres; (2) a single-arm, single-dose study of the leuprorelin implant; (3 and 4) two long-term studies with the leuprorelin implant administered twice, 12 or 16 weeks apart. Patients received 3-month leuprorelin (5 mg) implant or 3-month leuprorelin (10.72 mg) microspheres. Testosterone levels were analysed using radioimmunoassay or ultrasensitive liquid chromatography tandem mass spectrometry. Results: Both the leuprorelin implant and the leuprorelin microspheres achieved mean testosterone suppression (⩽0.5 ng/ml) within 4 weeks for >3 months. In both long-term, single-arm studies with the leuprorelin implant, median values of testosterone ⩽0.2 ng/ml were achieved at Week 4 and maintained until study completion (6 and 8 months); PSA decrease was also observed versus baseline. Conclusions: Long-lasting steady serum levels of testosterone, comparable with orchiectomy and consistent with the EAU-recommended castration level ( |
| Databáze: | OpenAIRE |
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