In 4 open-labels, single-arm, fixed dose, pivotal studies, male prostate cancer patients (age 40-86) were treated with 1, 3, 4, or 6-month SC-LA formulation. Blood was sampled at screening, baseline, 2, 4, 8 hours post dosing, days 1, 2, 3, 7, and every other week until end of each study. Serum T levels were measured by radioimmunoassay. Data were pooled across 4 studies and descriptive statistics were used to summarize concentrations at each time point and to determine time to T suppression.
The mean weight or age of patients was similar across all four studies. When patients were stratified by weight or age, the median serum T levels for all weight subgroups and all age subgroups achieved and maintained castration level by week 4 until the end of the study.
The authors therefore concluded that these results demonstrate that all SC-LA dose formulations consistently achieve and maintain T castration across all weight and age subgroups, including those with the highest BW (>90 kg) and age (>80 years). This suggests that weight does not require SCLA dose adjustment.
Presented by: Atkinson, S.
Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre.Twitter: @GoldbergHanan at the 37th Congress of Société Internationale d’Urologie - October 19-22, 2017- Lisbon, Portugal