Purpose: We summarized and critically assessed all available data from phas
e III clinical trials on complete androgen blockade versus surgical or medi
cal castration alone.
Materials and Methods: Published results in journals and abstracts of phase
III trials, and published meta-analyses were reviewed. We also reviewed qu
ality of life and toxicity issues associated with the addition of antiandro
gens to medical or surgical castration. Finally, we discuss the original ra
tionale for complete androgen blockade in the context of current knowledge.
Results: A total of 27 clinical trials using various combinations of androg
en deprivation were identified, of which 3 showed a statistically significa
nt benefit for the complete androgen blockade arm. There were 5 publication
s of meta-analyses that each used different selection criteria for the incl
usion of studies in the final analysis. Toxicity and quality of life have n
ot been widely investigated in prospective fashion but the available data s
uggest a higher toxicity rate and decreased quality of life with complete a
ndrogen blockade.
Conclusions: The extensive body of data does not support routine use of ant
iandrogens in combination with medical or surgical castration as first line
hormonal therapy in patients with metastatic prostate cancer.