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
(2017) In Therapeutic Advances in Urology 9(6). p.127-136- Abstract
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 (<0.2 ng/ml). Methods: Studies were conducted in patients with locally advanced/metastatic... (More)
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 (<0.2 ng/ml). 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 (<0.2 ng/ml), were achieved at Week 4 and maintained up to 8 months in men with advanced prostate cancer who received the leuprorelin implant.
(Less)
- author
- Solarić, Mladen ; Bjartell, Anders LU ; Thyroff-Friesinger, Ursula and Meani, Davide
- organization
- publishing date
- 2017-06-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- castration, hormones, leuprorelin, prostatic neoplasms, testosterone
- in
- Therapeutic Advances in Urology
- volume
- 9
- issue
- 6
- pages
- 127 - 136
- publisher
- SAGE Publications
- external identifiers
-
- pmid:28588651
- scopus:85019121096
- ISSN
- 1756-2872
- DOI
- 10.1177/1756287217701665
- language
- English
- LU publication?
- yes
- id
- 95988c76-7eb4-4f3a-8c41-bf48ff9adb5f
- date added to LUP
- 2017-06-07 16:14:28
- date last changed
- 2022-04-25 00:29:28
@article{95988c76-7eb4-4f3a-8c41-bf48ff9adb5f,
abstract = {{<p>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 (<0.2 ng/ml). 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 (<0.2 ng/ml), were achieved at Week 4 and maintained up to 8 months in men with advanced prostate cancer who received the leuprorelin implant.</p>}},
author = {{Solarić, Mladen and Bjartell, Anders and Thyroff-Friesinger, Ursula and Meani, Davide}},
issn = {{1756-2872}},
keywords = {{castration; hormones; leuprorelin; prostatic neoplasms; testosterone}},
language = {{eng}},
month = {{06}},
number = {{6}},
pages = {{127--136}},
publisher = {{SAGE Publications}},
series = {{Therapeutic Advances in Urology}},
title = {{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}},
url = {{http://dx.doi.org/10.1177/1756287217701665}},
doi = {{10.1177/1756287217701665}},
volume = {{9}},
year = {{2017}},
}