RANDOMIZED, PROSPECTIVE, CONTROLLED-STUDY COMPARING RADICAL PROSTATECTOMY ALONE AND NEOADJUVANT ANDROGEN WITHDRAWAL IN THE TREATMENT OF LOCALIZED PROSTATE-CANCER
Sl. Goldenberg et al., RANDOMIZED, PROSPECTIVE, CONTROLLED-STUDY COMPARING RADICAL PROSTATECTOMY ALONE AND NEOADJUVANT ANDROGEN WITHDRAWAL IN THE TREATMENT OF LOCALIZED PROSTATE-CANCER, The Journal of urology, 156(3), 1996, pp. 873-877
Purpose: A prospective, multicenter, randomized study was done to test
the hypothesis that neoadjuvant androgen withdrawal decreases the inc
idence of positive margins following radical prostatectomy for localiz
ed prostate cancer. Materials and Methods: Observations were made of 2
13 patients randomized to undergo radical prostatectomy alone (101) or
to receive a 12-week course of 300 mg, cyproterone acetate daily foll
owed by surgery (112). Groups were similar at baseline in terms of cli
nical stage, serum prostate specific antigen and Gleason score, Of 192
patients available for efficacy analysis 9 had stage T1b, 8 stage T1c
, 63 stage T2a, 36 stage T2b and 76 stage T2c disease. Results: One or
more positive surgical margins were found in 59 of 91 patients (64.8%
) in the surgery only group compared to 28 of 101 (27.7%) in the cypro
terone acetate group (p = 0.001). Patients who received preoperative t
herapy had a statistically significantly lower rate of apical margin i
nvolvement than those who did not (17.8 versus 47.8%, respectively, p
<0.0001). There was no statistically significant difference in surgica
l (p = 0.8645) or postoperative (p = 0.173) complications between the
2 groups. Conclusions: Neoadjuvant androgen withdrawal with a 12-week
course of 300 mg, cyproterone acetate daily results in a lower rate of
positive margins without adversely affecting postoperative recovery.
The impact on patient survival will be determined by long-term followu
p.