Background: low –dose ketoconazole (LDK) in combination with steroids has been
recognized as an effective secondary hormonal therapy in androgen-independent prostate
cancer (AIPC), we hypothesized that low-dose ketoconazole would likewise possess
efficacy and tolerabilitiy in the (AIPC).
Methods: in a single institution (Tishreen University Hospital, Lattakia), patients
with AIPC treated with LDK (at a dose of 200 mg orally 3 times daily ) as secondary
hormonal therapy with concomitant steroids were retrospectively identified, After
experiencing a rising prostate –specific antigen (PSA) level.
Results: 21 of 50 eligible patients)42%) treated with LDK experienced PSA declines
≥ 50% after the start of treatment, while there were 12 patients with low PSA between 25-
50% with a median duration of response (5.4 months) 7 patients less than 25 % decrease,
while 10 patients did not never respond. The most common complications is the fatigue
and general debility in 18 patients , digestive disorders in 21 patients (Summit, nausea and
diarrhea) , muscle disorders in 3 patients, and Metabolic disorders in five patients The
incidence of drug toxicity grade 3-4 is very few. There were only three patients not able to
continue the treatment due to severe side effects.
Conclusion: low dose ketokonazole and Predenisolone is a well – tolerated, relatively
inexpensive and clinically active treatment option. PSA response to low – dose
ketoconazole historically comparable to that of Abiraterone in patients with AIPC.
