PURPOSE:Intermittent androgen deprivation has been proposed to prolong hormone sensitivity and improve quality of life in patients with advanced prostate cancer. The FinnProstate Study VII has been performed to identify patients who might benefit from intermittent androgen deprivation. In this interim analysis we evaluated which prognostic markers affect the initial response to androgen deprivation therapy. MATERIALS AND METHODS: A total of 856 men with locally advanced or metastatic prostate cancer were enrolled and given androgen deprivation therapy for 24 weeks to ensure hormone sensitivity. Patients with hormone sensitive prostate cancer were randomized 1:1 to continuous androgen deprivation or intermittent androgen deprivation. The randomization criteria were prostate specific antigen decrease to less than 10 ng/ml or by more than 50% if less than 20 ng/ml at baseline. RESULTS: There were 292 patients (34%) who did not meet the randomization criteria (group 1). The remaining 564 patients (66%) were randomized to intermittent androgen deprivation or continuous androgen deprivation (group 2). Mean prostate specific antigen (834 vs 151 ng/ml), mean alkaline phosphatase (793 vs 292 IU/l), proportion of T4 tumors (37% vs 24%), poorly differentiated cancers (39% vs 26%), metastatic disease (82% vs 51%) and number of skeletal hot spots in M1 disease (more than 5 hot spots 72% vs 42%) were significantly higher in group 1 than in group 2. CONCLUSIONS:Patients with the most advanced prostate cancer and poorest prognosis do not show adequate biochemical prostate specific antigen response to androgen deprivation therapy but should be assessed for eligibility to receive nonendocrine treatment.
RCT Entities:
PURPOSE: Intermittent androgen deprivation has been proposed to prolong hormone sensitivity and improve quality of life in patients with advanced prostate cancer. The FinnProstate Study VII has been performed to identify patients who might benefit from intermittent androgen deprivation. In this interim analysis we evaluated which prognostic markers affect the initial response to androgen deprivation therapy. MATERIALS AND METHODS: A total of 856 men with locally advanced or metastatic prostate cancer were enrolled and given androgen deprivation therapy for 24 weeks to ensure hormone sensitivity. Patients with hormone sensitive prostate cancer were randomized 1:1 to continuous androgen deprivation or intermittent androgen deprivation. The randomization criteria were prostate specific antigen decrease to less than 10 ng/ml or by more than 50% if less than 20 ng/ml at baseline. RESULTS: There were 292 patients (34%) who did not meet the randomization criteria (group 1). The remaining 564 patients (66%) were randomized to intermittent androgen deprivation or continuous androgen deprivation (group 2). Mean prostate specific antigen (834 vs 151 ng/ml), mean alkaline phosphatase (793 vs 292 IU/l), proportion of T4 tumors (37% vs 24%), poorly differentiated cancers (39% vs 26%), metastatic disease (82% vs 51%) and number of skeletal hot spots in M1 disease (more than 5 hot spots 72% vs 42%) were significantly higher in group 1 than in group 2. CONCLUSIONS:Patients with the most advanced prostate cancer and poorest prognosis do not show adequate biochemical prostate specific antigen response to androgen deprivation therapy but should be assessed for eligibility to receive nonendocrine treatment.
Authors: Ashraf J Abusamra; Shouki Bazarbashi; Yasser Bahader; Hussain Kushi; Danny Rabah; Dany Rabbah; Naser Al Bogami; Khalid Al Ghamdi; Abdullah Al Ghamdi; Khaled Balaraj; Raouf Seyam; Mohammed Al Otaibi; Eyad Al Saeed Journal: Urol Ann Date: 2011-03