OBJECTIVE To assess the efficacy of ketoconazole in patients with castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS From April 2008 to November 2009, 37 patients with CRPC have been treated with ketoconazole. The primary endpoint was the prostate-specific antigen (PSA) response; the secondary endpoints were progression-free survival and safety profile. Ketoconazole was administered by oral route at a dose of 200 mg every 8 h continuous dosing until the onset of serious adverse events or disease progression. The study was based on a two-step design with an interim efficacy analysis carried out on the first 12 patients accrued. RESULTS Main characteristics of population were: median age 75 years (range 60-88); baseline mean PSA 28.8 ng/mL (4.3-1000); 30 patients previously challenged with at least two lines of hormone therapy; 15 patients previously treated with chemotherapy. Biochemical responses accounted for: two complete responses (5%), six partial responses (16%), 13 patients with stable disease (35%), and 14 with progressive disease (38%). Of 15 patients resistant to chemotherapy, overall disease control (complete plus partial responses plus stable disease) was recorded in seven of them. Treatment was feasible without inducing grade 3-4 adverse events. The most common grade 1-2 adverse events were asthenia (27%), vomiting (8%) and abdominal pain (8%). CONCLUSION Treatment with low-dose ketoconazole is feasible and well tolerated. The efficacy was satisfactory in patients previously treated with chemotherapy.

Low dose of ketoconazole in patients with prostate adenocarcinoma resistant to pharmacological castration / G. Procopio, V. Guadalupi, M. Giganti, L. Mariani, R. Salvioni, N. Nicolai, F. Capone, R. Valdagni, E. Bajetta. - In: BJU INTERNATIONAL. - ISSN 1464-4096. - 108:2(2011 Jul), pp. 223-227.

Low dose of ketoconazole in patients with prostate adenocarcinoma resistant to pharmacological castration

R. Valdagni;
2011-07

Abstract

OBJECTIVE To assess the efficacy of ketoconazole in patients with castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS From April 2008 to November 2009, 37 patients with CRPC have been treated with ketoconazole. The primary endpoint was the prostate-specific antigen (PSA) response; the secondary endpoints were progression-free survival and safety profile. Ketoconazole was administered by oral route at a dose of 200 mg every 8 h continuous dosing until the onset of serious adverse events or disease progression. The study was based on a two-step design with an interim efficacy analysis carried out on the first 12 patients accrued. RESULTS Main characteristics of population were: median age 75 years (range 60-88); baseline mean PSA 28.8 ng/mL (4.3-1000); 30 patients previously challenged with at least two lines of hormone therapy; 15 patients previously treated with chemotherapy. Biochemical responses accounted for: two complete responses (5%), six partial responses (16%), 13 patients with stable disease (35%), and 14 with progressive disease (38%). Of 15 patients resistant to chemotherapy, overall disease control (complete plus partial responses plus stable disease) was recorded in seven of them. Treatment was feasible without inducing grade 3-4 adverse events. The most common grade 1-2 adverse events were asthenia (27%), vomiting (8%) and abdominal pain (8%). CONCLUSION Treatment with low-dose ketoconazole is feasible and well tolerated. The efficacy was satisfactory in patients previously treated with chemotherapy.
castration-resistant prostate cancer; docetaxel; ketoconazole; pharmacological castration; prostate-specific antigen response; Urology
Settore MED/36 - Diagnostica per Immagini e Radioterapia
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/656569
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