Neoadjuvant hormonal therapy (NHT) prior to radical prostatectomy or radiat
ion therapy for clinically localized prostate cancer has regained interest
in recent years but proof of its clinical benefit with respect to patient s
urvival is still pending. We reviewed the literature regarding NHT in prost
ate cancer; only studies with a high evidence level were included for analy
sis. Five prospective randomized trials of NHT in radical prostatectomy-tre
ated patients could be identified. Despite significantly lower numbers of p
ositive surgical margins in the NHT group, prostate specific antigen failur
e rates were similar in the NHT group and the surgery only group. Data on d
isease-free and overall survival are not yet available. The two prospective
randomized studies of NHT in radiation-treated patients could demonstrate
better local control of the tumor in the NHT group. However, there was no d
ifference in overall survival between the NHT arm and the radiation only ar
m, Future clinical research should consider type and duration of hormonal t
reatment and evaluate potential surrogate end points. To date, there is no
hard evidence in favor of NHT prior to radical prostatectomy or external be
am irradiation. NHT in prostate cancer should only be applied within contro
lled trials.