Six-month leuprorelin acetate depot formulations in advanced prostate cancer: a clinical evaluation

Ulf W Tunn,1 Damian Gruca,2 Peter Bacher3 1Urological Department, Prostate Center, Offenbach, Germany; 2AbbVie Deutschland GmbH and Co, KG, Ludwigshafen, Germany; 3AbbVie, North Chicago, IL, USA Abstract: For nearly three decades, gonadotropin-releasing hormone (GnRH) agonists, particularly leuprorelin acetate (LA), have served as an important part of the treatment armamentarium for prostate cancer. The introduction of LA depot formulations provided a significant improvement in the acceptance of this therapy; however, their indicated treatment duration of 1 to 4 months was still not long enough to satisfy all medical needs. For this reason some manufacturers developed new injectable formulations that provide testosterone suppression for 6 months. This review article assesses key publications in order to compare these long-acting, commercially available, LA depot formulations and their clinical performance. The literature search identified 14 publications; by excluding reviews, duplications, and non-English articles, only three original papers describing clinical trial remained for review: two focused on microsphere-based LA formulations with either a 30 mg or 45 mg dose and one focused on a gel-based leuprorelin acetate with a 45 mg dose. All products were tested in individual clinical trials and have demonstrated their efficacy and safety. Keywords: androgen deprivation therapy, GnRH agonist, leuprorelin acetate, prostate cancer, leuprolide acetate