8 3.2.2. Post-Marketing Clinical Trials and Analyses Post-marketing studies conrmed the LA gel depot's effectiveness in routine clinical practice, showing consistent testosterone suppression and PSA reduction across diverse patient populations, including those switching from other therapies. 3.2.2.1 Effectiveness and safety of the 6-month LA gel depot formulation for the treatment of advanced PCa in routine clinical practice This prospective observational study included a total of 1,273 PCa patients that were involved and observed for 1 year. The study conrmed the effectiveness and safety of the 6-month LA gel depot formulation in routine urological practice. 3.2.2.2. Effectiveness and tolerability of 1- and 3-month LA gel depot formulations for treating advanced PCa in routine clinical practice This prospective observational study, conducted in Belgium (MANTA study), evaluated the effectiveness and tolerability of the 1- and 3-month LA gel depot formulations in 243 prostate cancer (PCa) patients over a minimum period of 3 months. Results showed a 94% reduction in median testosterone levels (from 360 ng/dL to 20 ng/dL) and a 95% reduction in median PSA levels (from 12 ng/mL to 0.6 ng/mL). 3.2.2.3. Effectiveness of LA gel depot to achieve low nadir testosterone in PCa patients This study assessed the ability of the LA gel depot to achieve low nadir testosterone levels, which are associated with delayed disease progression and improved survival. Data from pivotal trials showed that the LA gel depot consistently reduced testosterone levels to ≤20 ng/dL within 4 weeks and ≤10 ng/dL by 5 weeks. The suppression was maintained consistently across all formulations, with 100% of patients achieving testosterone ≤50 ng/dL, 94–99% achieving ≤20 ng/dL, and 66–85% achieving ≤10 ng/dL. These results highlight the depot's effectiveness in maintaining low testosterone levels critical for improved clinical outcomes. 3.2.2.4. Evaluation of the LA Gel Depot in Achieving and Maintaining Castrate Testosterone Levels This analysis evaluated the ability of the LA gel depot to reduce and maintain testosterone levels ≤20 ng/dL in 348 advanced prostate cancer (PCa) patients across three formulations (1-month, 3-month, and 6-month). Results showed that testosterone suppression was achieved within 6 weeks in 90–96% of patients, with 90–97% maintaining suppression throughout the study. Mean testosterone levels at the end of therapy were ≤20 ng/dL for all formulations: 6 ng/dL (1-month), 10 ng/dL (3-month), and 13 ng/dL (6-month). The study conrmed the depot's effectiveness in achieving consistent and durable testosterone suppression. 3.2.2.5. Evaluation of the Pharmacokinetics of the LA Gel Depot and the Impact of Age and Body Weight on Testosterone Reduction This analysis assessed the pharmacokinetics (PK) and pharmacodynamics (PD) of the LA gel depot in advanced prostate cancer (PCa) patients, focusing on the inuence of age and body weight. Results showed that leuprorelin acetate levels were consistently maintained between 0.05 and 1 ng/mL from week 6 to week 24 across all formulations (1-, 3-, and 6month). Age and body weight did not affect testosterone suppression, which was achieved and maintained in all subgroups, including patients with higher body weights (>120 kg) and younger ages (<60 years). The study conrmed the depot's consistent and long-lasting drug delivery and effectiveness, regardless of patient demographics. 3.2.2.6. Comparison of Subcutaneous and Intramuscular Leuprorelin Acetate Formulations This study compared the pharmacokinetics (PK) and pharmacodynamics (PD) of the 1month LA gel depot (subcutaneous) with the 7.5 mg intramuscular leuprorelin acetate (IMLA).
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