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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

Solarić, Mladen; Bjartell, Anders LU ; Thyroff-Friesinger, Ursula and Meani, Davide (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.

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author
publishing date
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
external identifiers
  • scopus:85019121096
ISSN
1756-2872
DOI
10.1177/1756287217701665
language
English
LU publication?
no
id
95988c76-7eb4-4f3a-8c41-bf48ff9adb5f
date added to LUP
2017-06-07 16:14:28
date last changed
2017-09-07 03:00:14
@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 (&lt;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 &gt;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 (&lt;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},
  keyword      = {castration,hormones,leuprorelin,prostatic neoplasms,testosterone},
  language     = {eng},
  month        = {06},
  number       = {6},
  pages        = {127--136},
  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},
  volume       = {9},
  year         = {2017},
}