RANDOMIZED STUDY OF NEOADJUVANT TESTICULAR ANDROGEN ABLATION THERAPY BEFORE RADICAL PROSTATECTOMY IN MEN WITH CLINICALLY LOCALIZED PROSTATE-CANCER

Purpose: We determined whether 12 weeks of neoadjuvant testicular andr ogen ablation therapy using a luteinizing hormone-releasing hormone ag onist could improve pathological outcomes in men undergoing radical re tropubic prostatectomy for clinically localized (stages T1C, T2A and T 2B) prostatic carcinoma. Materials and Methods: A total of 56 particip ants was randomized to receive either monthly injections of a luteiniz ing hormone-releasing hormone agonist at 4-week intervals followed by radical retropubic prostatectomy (28) or to undergo immediate radical retropubic prostatectomy alone (28). Operations were performed via a s imilar technique and all prostatic specimens were processed histologic ally in their entirety. Results: There was no improvement in pathologi cal outcome using a luteinizing hormone-releasing hormone agonist preo peratively compared to surgery alone. Of 28 men undergoing immediate r adical retropubic prostatectomy 23 had organ-confined (17) or specimen -confined (6) disease versus 22 of 28 who received luteinizing hormone -releasing hormone neoadjuvant therapy for 12 weeks preoperatively (16 with organ-confined and 6 with specimen-confined disease, p = 1.00). In addition, when the study population was analyzed by pretreatment pr ostate specific antigen (PSA) levels (10 ng./ml. or less, or greater t han 10 ng./ml.) there was also no difference in pathological outcome ( p = 0.65 for PSA greater than 10 and p = 0.32 for PSA less than 10). C onclusions: Neoadjuvant androgen ablation therapy for 12 weeks before radical prostatectomy in patients with clinically localized adenocarci noma of the prostate does not result in improved pathological outcomes .