PURPOSE: In the initial report of the Lupron Depot Neoadjuvant Prostate Cancer Study Group patients who received 3 months of androgen deprivation had a significant decrease in the positive margin rate. We monitored these patients for 5 years and to our knowledge present the longest followup of any neoadjuvant trial. MATERIALS AND METHODS: A multi-institutional prospective randomized trial was performed between February 1992 and April 1994 involving patients with stage cT2b prostate cancer, including 138 who received 3 months ofleuprolide plus flutamidebefore radical prostatectomy and 144 who underwent radical prostatectomy only. Patients were followed every 6 months with serum prostate specific antigen (PSA) testing for 5 years. Biochemical recurrence was defined as PSA greater than 0.4 ng./ml. RESULTS: At 5 years there was no difference in the biochemical recurrence rate. PSA was less than 0.4 ng./ml. in 64.8% of the patients in the neoadjuvant androgen ablation plus prostatectomy and 67.6% in the prostatectomy only group (p = 0.663). CONCLUSIONS: Although 3 months of androgen deprivation before radical prostatectomy resulted in an apparently significant decrease in positive surgical margins, a 5-year followup does not indicate any difference in the recurrence rate. Until studies document improvement in biochemical or clinical recurrence with longer periods of treatment, induction androgen deprivation before radical prostatectomy is not indicated.
RCT Entities:
PURPOSE: In the initial report of the Lupron Depot Neoadjuvant Prostate Cancer Study Group patients who received 3 months of androgen deprivation had a significant decrease in the positive margin rate. We monitored these patients for 5 years and to our knowledge present the longest followup of any neoadjuvant trial. MATERIALS AND METHODS: A multi-institutional prospective randomized trial was performed between February 1992 and April 1994 involving patients with stage cT2b prostate cancer, including 138 who received 3 months of leuprolide plus flutamide before radical prostatectomy and 144 who underwent radical prostatectomy only. Patients were followed every 6 months with serum prostate specific antigen (PSA) testing for 5 years. Biochemical recurrence was defined as PSA greater than 0.4 ng./ml. RESULTS: At 5 years there was no difference in the biochemical recurrence rate. PSA was less than 0.4 ng./ml. in 64.8% of the patients in the neoadjuvant androgen ablation plus prostatectomy and 67.6% in the prostatectomy only group (p = 0.663). CONCLUSIONS: Although 3 months of androgen deprivation before radical prostatectomy resulted in an apparently significant decrease in positive surgical margins, a 5-year followup does not indicate any difference in the recurrence rate. Until studies document improvement in biochemical or clinical recurrence with longer periods of treatment, induction androgen deprivation before radical prostatectomy is not indicated.
Authors: Elahe A Mostaghel; Peter S Nelson; Paul Lange; Daniel W Lin; Mary Ellen Taplin; Steven Balk; William Ellis; Philip Kantoff; Brett Marck; Daniel Tamae; Alvin M Matsumoto; Lawrence D True; Robert Vessella; Trevor Penning; Rachel Hunter Merrill; Roman Gulati; Bruce Montgomery Journal: J Clin Oncol Date: 2013-12-09 Impact factor: 44.544
Authors: Jonathan L Silberstein; Stephen A Poon; Daniel D Sjoberg; Alexandra C Maschino; Andrew J Vickers; Aaron Bernie; Badrinath R Konety; W Kevin Kelly; James A Eastham Journal: BJU Int Date: 2015-04-17 Impact factor: 5.588
Authors: Peiguo G Chu; Sean K Lau; Lawrence M Weiss; Mark Kawachi; Jeffrey Yoshida; Christopher Ruel; Rebecca Nelson; Laura Crocitto; Timothy Wilson Journal: Surg Endosc Date: 2008-09-24 Impact factor: 4.584