ArticleTherapeutic advances in medical oncology2024
Effectiveness, pharmacokinetics, and safety of triptorelin acetate microspheres in patients with locally advanced and metastatic prostate cancer.
Article in Therapeutic advances in medical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: A newly generic microspheres, sustained-release formulation of triptorelin acetate 3.75 mg has been developed. Objectives: To evaluate the efficacy, pharmacokinetics, and safety of triptorelin 1-month formulation in Chinese patients with prostate cancer. Design: An open-label, multicenter clinical trial with one arm testing a 1-month sustained-release triptorelin formulation in prostate cancer patients. Methods: Patients with prostate cancer received three consecutive 28-day injections of triptorelin acetate. The primary endpoint was the proportion of successful patients over the total number of evaluable patients. Treatment success was defined as testosterone suppression below the clinical castration level (i.e., <0.5 ng/mL) at day 28 and maintenance of clinical castration until study completion (day 84). The frequency of patients with testosterone concentrations <0.2 ng/mL was also studied. Results: The study included 125 patients. All 125 patients received at least one dose of the study drug and 122 completed the study. The successful patient proportion among the evaluable patients was 97.6% (122/125; 95% CI, 92.7-99.2). 95.1% (116/122) achieved testosterone concentrations <0.2 ng/mL. The pharmacokinetic profile of triptorelin during the first 3 months of treatment, evaluated in a subset of the study population ( Conclusion: 3.75-mg Triptorelin acetate microspheres for injection were effective in achieving and maintaining testosterone suppression and were well tolerated in patients with prostate cancer. Trial registration: chictr.org.cn (ChiCTR2000033188).
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