UROLOGICAL ONCOLOGY

Long-term followup of a randomized trial of 0 versus 3 months of neoadjuvant androgen ablation before radical prostatectomy
Klotz LH, Goldenberg SL, Jewett MA, Fradet Y, Nam R, Barkin J, Chin J, Chatterjee S; Canadian Uro-Oncology Group
Division of Urology, Sunnybrook and Women’s College Health Sciences Centre MG408, 2075 Bayview
Avenue, Toronto, Ontario M4N 3M5, Canada
J. Urol. 2003; 170: 791-4

• Purpose: In 1992 we initiated a national randomized prospective trial of 3 months of cyproterone acetate before radical prostatectomy compared to prostatectomy alone. Initial results indicated a 50% decrease in the rate of positive surgical margins. This decrease did not translate into a difference in prostate specific antigen (PSA) progression at 3 years. This report is on the long-term outcome (median followup 6 years) of this cohort.
• Materials and Methods: This prospective, randomized, open label trial compared 100 mg cyproterone acetate 3 times daily for 3 months before surgery to surgery alone. Randomization occurred between January 1993 and April 1994. Patients were stratified according to clinical stage, baseline serum PSA and Gleason sum. A total of 213 patients were accrued. Biochemical progression was defined as 2 consecutive detectable PSAs (greater than 0.2 ng/ml) at least 4 weeks apart, re-treatment or death from prostate cancer.
• Results: A total of 34 (33.6%) patients undergoing surgery only and 42 (37.5%) patients given neoadjuvant hormone therapy (NHT) had biochemical recurrence during the median followup of 6 years. Despite the significant pathological down staging in this study, there was no significant difference in number of patients with no evidence of biochemical disease (bNED) survival (p = 0.732). A bNED survival benefit favoring NHT was seen in men with a baseline PSA greater than 20 (p = 0.015).
• Conclusions: After 6 years of followup there was no overall benefit with 3 months of NHT. Improved bNED survival was seen in the highest risk PSA group (PSA greater than 20). The possibility that high risk patients may benefit from NHT warrants further investigation.
  
  
• Editorial Comment
  Once upon a time, neoadjuvant hormonal therapy before prostatectomy was a hit on our congresses. We were told that surgical margins were less positive, and we should do that in every case. After several years now this claim is indeed history. Neoadjuvant hormonal therapy before prostatectomy did not translate in improved survival. With regard to side effects and the psychological impacts of this therapy on men this should not be advocated anymore.

Dr. Andreas Böhle
Professor of Urology
HELIOS Agnes Karll Hospital
Bad Schwartau, Germany