Is ''off-protocol'' chemotherapy for androgen-independent carcinoma of prostate warranted?

Hormone-refractory prostate cancer (HRPC) is difficult to treat adequately, and current modalities such as second-line hormone therapy provide low response rates and poor palliation. Cytotoxic chemotherapy historically yields objective responses in less than 20% of patients; however, recent trials using prostate-specific antigen (PSA) and quality-of-life surrogate endpoints have reported response rates up to 60% with minimal toxicity. In view of these recent trials, it is clearly justifiable to treat patients ineligible for protocols with off-protocol agents.