Phase II Trial Assessing Granulocyte-macrophage—Colony Stimulating Factor, Ketoconazole Plus Mitoxantrone in Metastatic Castration-resistant Prostate Cancer Progressing After Docetaxel Treatments

Abstract

Introduction: This study evaluated objective response and safety for the combination of granulocyte macrophage-colony stimulating factor (GM-CSF), ketoconazole, and mitoxantrone in castration-resistant prostate cancer (CRPC) patients who previously failed docetaxel-based chemotherapy. Methods: Treatment consisted of 400 mg TID ketoconazole, 12 mg/m² mitoxantrone every 3 weeks, and 250 μg/m² GM-CSF. Results: Twenty-nine patients were evaluable for response. Median overall survival (OS) for all patients was 18.03 months. Patients with a higher PSA decrease experienced an increased OS and progression-free survival (PFS). Conclusion: This combination demonstrated significant antitumor activity with reversible toxicity in CRPC patients who previously failed docetaxel-based therapy.

Keywords: :

• Prostate cancer
• Granulocyte macrophage-colony stimulating factor
• Ketoconazole
• Mitoxantrone