Palliative Rx for prostate ca wins OK from FDA
Trelstar (22.5 mg triptorelin pamoate) has received FDA marketing approval as a twice-yearly intramuscular gonadotropin-releasing hormone (GnRH) agonist.
Trelstar (22.5 mg triptorelin pamoate) has received FDA marketing approval as a twice-yearly intramuscular gonadotropin-releasing hormone (GnRH) agonist. Trelstar suppresses testosterone production for six months, according to manufacturer Watson Pharmaceuticals. Approval was based on a 12-month, phase III efficacy and safety study of Trelstar given every six months in patients with advanced disease. Trelstar produced a mean testosterone serum level of 12.8 ng/dL from month two through month 12, which was well below castration levels associated with androgen deprivation therapy, according to Watson.
By day 29, 97.5% of the clinical trial patients achieved castrate level, and more than 98% of all patients were below castrate level at month six and month 12. Median prostate-specific antigen (PSA) was also reduced by 96.4% at the end of the study. The most commonly reported adverse event was hot flushes (71.7%).
Prolaris in Practice: Guiding ADT Benefits, Clinical Application, and Expert Insights From ACRO 2025
April 15th 2025Steven E. Finkelstein, MD, DABR, FACRO discuses how Prolaris distinguishes itself from other genomic biomarker platforms by providing uniquely actionable clinical information that quantifies the absolute benefit of androgen deprivation therapy when added to radiation therapy, offering clinicians a more precise tool for personalizing prostate cancer treatment strategies.
