Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: An open-label, non-comparative, multicentre, phase III study
Date
2009
Authors
Lundstrom E.A.
Rencken R.K.
Van Wyk J.H.
Coetzee L.J.E.
Bahlmann J.C.M.
Reif S.
Strasheim E.A.
Bigalke M.C.
Pontin A.R.
Goedhals L.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Background and Objectives: Triptorelin 6-month formulation was developed to offer greater convenience to both patients and physicians by reducing the injection frequency. The efficacy, pharmacokinetics and safety of a new 6-month formulation of triptorelin were investigated over 12 months (48 weeks). The primary objective was to evaluate the formulation in achieving castrate serum testosterone levels (≤1.735 nmol/L or ≤50 ng/dL) on day 29 and in maintaining castration at months 2-12. Absence of luteinizing hormone (LH) stimulation and change in prostate-specific antigen (PSA) level were also assessed. Methods: An open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa. Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5mg at an interval of 24 weeks. In all patients, testosterone (primary outcome measurement) was measured at baseline and then every 4 weeks; LH was measured before and 2 hours after the two injections. PSA was measured on day 1 and at weeks 12, 24, 36 and 48. Adverse events were recorded at each visit. Results: In the intent-to-treat population, 97.5% (95% CI 92.9, 99.5) of patients achieved castrate serum testosterone levels by day 29, and 93.0% (95% CI 86.8, 97.0) maintained castration at months 2-12. After the second injection, 98.3% of patients showed absence of LH stimulation. The most frequent drug-related adverse events were hot flushes (71.7% of patients). No patient withdrew from the study as a result of an adverse event. Conclusions: The triptorelin 6-month formulation was well tolerated and was able to achieve and maintain castration for the treatment of locally advanced and metastatic prostate cancer. By reducing the frequency of required injections, this new formulation offers a more convenient treatment regimen. © 2009 Adis Data Information BV. All rights reserved.
Description
Keywords
luteinizing hormone, prostate specific antigen, testosterone, triptorelin, abscess, adult, advanced cancer, aged, alanine aminotransferase blood level, article, aspartate aminotransferase blood level, clinical trial, drug efficacy, drug formulation, drug safety, drug tolerability, erectile dysfunction, hot flush, human, hypertension, injection site pain, injection site reaction, major clinical study, male, metastasis, multicenter study, open study, phase 3 clinical trial, priority journal, prostate cancer, side effect, testis atrophy, testosterone blood level, tumor, Aged, Antineoplastic Agents, Hormonal, Delayed-Action Preparations, Hot Flashes, Humans, Injections, Intramuscular, Male, Middle Aged, Neoplasm Metastasis, Prostate-Specific Antigen, Prostatic Neoplasms, South Africa, Testosterone, Triptorelin
Citation
Clinical Drug Investigation
29
12
29
12