Phase II trial of external beam radiation with @entity11256 ( @entity11256 ) for the treatment of locally advanced XXXX .

@entity1 @entity137 @entity263 @entity11256 @entity3 @entity20292
PURPOSE: To evaluate the efficacy and @entity137 of the addition of @entity11256 ( @entity20292 ) to external beam radiation. METHODS AND MATERIALS: Fifty eight previously untreated @entity1 with locally advanced @entity263 were entered on a Phase II trial of @entity11256 ( @entity20292 ) combined with standard external beam radiation therapy. @entity20292 was given concurrently with irradiation. Four @entity1 received less than 25% of the intended dose of @entity20292 and were ineligible for further analysis. The stage of the remaining @entity1 were T2c-11, T3-39, T4-1, bulky local recurrence after prostatectomy-1, and T3, N1-2. RESULTS: Forty-five of 54 @entity1 (83.3%) achieved a clinical complete response (CCR) in the prostate and seminal vesicles as judged by digital rectal exam (DRE). Responses were rapid with a median time to CCR of 3.4 months, range 0-22.8 months. Local control was maintained in 82% of the @entity1 who achieved a CCR. Fifteen of 32 eligible @entity1 with a normal DRE underwent prostate biopsies from 12-20 months after treatment, seven had negative biopsies (46.6%). Distant @entity3 occurred in 18 @entity1 (33.3%). Pretreatment prostatic specific antigen (PSA), Gleason score, and stage were not associated with treatment outcome in a univariate analysis. CONCLUSION: While @entity20292 plus radiation was associated with a rapid CCR, the overall treatment outcome of these @entity1 appeared to be similar to published reports of @entity1 receiving RT alone. The rapid response rate may imply biologic activity of the @entity20292 . In future trials, it may be reasonable to focus on @entity1 at lower risk for the subsequent development of distant disease.
