Pharmacodynamic equivalence of a decapeptyl 3-month SR formulation with the 28-day SR formulation in patients with advanced prostate cancer
Date
2004
Authors
Teillac P.
Heyns C.F.
Kaisary A.V.
Bouchot O.
Blumberg J.
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Abstract
Aims: The objective of the study was to assess the pharmacodynamic equivalence of LHRH analogue triptorelin 3-month and 28-day SR formulations. Methods: Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68). Group-chemical castration rates defined as the percentage of patients reaching a testosterone plasma level ≤0.5 ng/ml were compared at D84 (i.e., 3 x 28 days). Testosterone, LH and triptorelin plasma profiles, and change from baseline in plasma PSA were assessed over 3 months (from baseline to D91). Results: Chemical castration rates were 98 and 96% in the 3-month and 28-day formulation groups, respectively, with confidence interval (two-sided 94.2% CI) of [-8.1%; 9.6%]. Median times to reach chemical castration were 18.8 and 18.5 days (p = 0.86, log rank), respectively. Ratios for mean peak plasma levels and AUC91 of the two formulations for both testosterone and LH fell within the [0.80; 1.25] equivalence interval. Mean PSA decreases from baseline at D91 were 91.0 and 91.7%, respectively (p = 0.73). Conclusion: Treatments with the two triptorelin formulations over 3 months are pharmacologically equivalent. Copyright © 2004 S. Karger AG, Basel.
Description
Keywords
flutamide, gonadorelin derivative, luteinizing hormone, prostate specific antigen, testosterone, triptorelin, adult, advanced cancer, aged, area under the curve, article, cancer localization, clinical trial, confidence interval, controlled clinical trial, controlled study, fatigue, female, gastrointestinal symptom, headache, hot flush, human, impotence, libido disorder, luteinizing hormone blood level, major clinical study, male, metastasis, multicenter study, musculoskeletal disease, pain, priority journal, prostate carcinoma, randomized controlled trial, side effect, slow release formulation, testosterone blood level, Aged, Antineoplastic Agents, Hormonal, Delayed-Action Preparations, Drug Administration Schedule, Humans, Luteinizing Hormone, Male, Middle Aged, Neoplasms, Hormone-Dependent, Orchiectomy, Prostatic Neoplasms, Testosterone, Therapeutic Equivalency, Triptorelin
Citation
Hormone Research
62
5
62
5