Biomodulatory Treatment of @entity1 with Castration-Resistant Prostate Cancer: A Phase II Study of XXXX with @entity12098 , @entity14296 , @entity619 and Low-Dose @entity21193 .

@entity1 @entity137 @entity263 @entity12098 @entity619 @entity1486 @entity14296 @entity2213 @entity21193
Therapeutic options for @entity1 with @entity263 ( @entity263 ) remain limited. In a multicenter, Phase II study, 65 @entity1 with histologically confirmed @entity263 received a biomodulatory regimen during the six-month core study. Treatment comprised daily doses of @entity2213 , @entity12098 , @entity14296 , @entity21193 and @entity619 . The primary endpoint was @entity1486 response. Responders could enter an extension phase until disease progression or intolerable @entity137 occurred. Mean @entity1486 was 45.3  ng/mL at baseline, and 77  % of @entity1 had a @entity1486 doubling time <3  months. Of the 61 evaluable @entity1 , 37 @entity1 (60.6  %) responded or had stable disease and 23 of them (37.7  % of 61 @entity1 ) were @entity1486 responders. Among the 23 responders mean @entity1486 decreased from 278.9        784.1  ng/mL at baseline to 8.8        11.6  ng/mL at the final visit (week 24). The progression-free survival (PFS) was 467  days in the ITT population. Of the 947 adverse events, 57.6  % were suspected to be drug-related, 13.8  % led to dose adjustment or permanent discontinuation and 40.2  % required concomitant medication. This novel combination approach led to an impressive @entity1486 response rate of 37.7  % in @entity263 @entity1 . The good @entity1486 response and PFS rate combined with the manageable @entity137 profile suggest an alternative treatment option.
