Effectiveness and tolerance of three month sustained release leuprorelin in the treatment of metastatic prostatic cancer (comparative, randomized, multicentric study
Zerbib, M.; Lucas, C.; Leblanc, V.
Progres en Urologie Journal de l'Association Francaise d'Urologie et de la Societe Francaise d'Urologie 7(2): 246-253
1997
ISSN/ISBN: 1166-7087 PMID: 9264767 Document Number: 476387
To establish the pharmacodynamic and safety equivalence between 2 sustained-release forms of leuprorelin 11.25 mg and 3.75 mg, in the treatment of metastatic prostatic carcinoma. 44 patients received subcutaneous injections of leuprorelin for 9 months (randomization: 2/l): either 11.25 mg every three months (n = 29) or 3.75 mg monthly (n = 15). Main criterion: centralized monthly assay of plasma testosterone (T). The equivalence of the 2 forms in terms of mean plasma testosterone was demonstrated (p = 0.002): 1 month: T = 0.19 +/- 0.03 ng/ml; 3 months: T = 0.27 +/- 0.04 ng/ml. Exploratory analysis did not reveal any significant difference between the groups for the number of patients castrated at each visit or for the number of patients with all T values < or = 0.5 ng/ml, or for clinical responses or safety. The 2 forms have a comparable efficacy and safety.