Targeting FSH in @entity342 -independent XXXX : abarelix for @entity263 progressing after orchiectomy.

@entity1 @entity4396 @entity263 @entity56 @entity342 @entity1486
OBJECTIVES: To determine the efficacy of the @entity4396 antagonist abarelix in @entity1 with @entity342 -independent @entity263 progressing after orchiectomy and to measure its effect on serum follicle-stimulating hormone (FSH). METHODS: Sixteen @entity1 with @entity263 progressing after orchiectomy received abarelix-depot 100 mg by intramuscular injection on days 1, 15, and 29 and then every 28 days for up to 24 weeks (52 weeks in @entity1 who met the criteria for a @entity1486 [PSA] response after 24 weeks). PSA response was the primary endpoint and was defined as a 50% reduction confirmed 4 weeks later. The time to progression and effect of therapy on serum FSH were secondary endpoints. RESULTS: No @entity1 met the criteria for a PSA response. Five @entity1 (31%, 95% confidence interval 11% to 58%) experienced confirmed reductions in the PSA level ranging from 9.3% to 31.8%. At the end of the six cycles of therapy, 6 @entity1 remained stable without PSA progression or other signs of disease progression. The median time to progression was 12 weeks (95% confidence interval 6 to 18). The mean serum FSH concentration declined after 4 weeks of study treatment by nearly 90% from a baseline of 45.1 IU/L (95% confidence interval 34.0 to 56.2) and remained suppressed throughout the observation period. Treatment was well tolerated, with one grade 3 @entity56 . CONCLUSIONS: Treatment with abarelix in @entity1 with @entity342 -independent @entity263 after orchiectomy results in marked reduction in circulating FSH. None of the @entity1 met the PSA response criteria; nonetheless, minor reductions in serum PSA were observed in 5 of 16 @entity1 .
