[Effectiveness and tolerance of three month sustained release leuprorelin in the treatment of metastatic prostatic cancer (comparative, randomized, multicentric study].
OBJECTIVE
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.


METHODS
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).


RESULTS
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.


CONCLUSIONS
The 2 forms have a comparable efficacy and safety.
Zerbib
M
M
Groupe Hospitalier Cochin, Paris, France.
Lucas
C
C
Leblanc
V
V
D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy*; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000737:chemistry / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D006801:Humans; D016729:Leuprolide / Q000737:chemistry / Q000627:therapeutic use*; D008297:Male; D009362:Neoplasm Metastasis; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D013739:Testosterone / Q000097:blood; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D003692:Delayed-Action Preparations; D013739:Testosterone; D017430:Prostate-Specific Antigen; D016729:Leuprolide