Lycopene: a novel drug therapy in hormone refractory metastatic prostate cancer

Objective: In a prospective study we evaluated the efficacy of lycopene for the treatment of patients with metastatic hormone refractory prostate cancer. Material and Methods: Between January 2001 and December 2002, 20 consecutive patients (median age 72; range 56-9)) with metastatic HRPC were enrolled in the study. Lycopene in the dose of 10 mg/day was administered for a period of 3 months. Inclusion criteria were patients previously treated with hormonal therapy now with clinical and biochemical evidence of disease progression. A complete response (CR) was defined as a normalization of PSA (<4 ng/mL) and the disappearance of any sign of disease for at least 8 weeks. A partial response was defined as a >50% decrease in PSA level for at least 8 weeks associated with improvement (or no worsening) in ECOG PS and relief of bone pain if present. Stable disease (SD) was defined as a <50% decrease or <25% increase in the PSA level associated with no worsening of ECOG PS and/or bone pain for at least 8 weeks. Results: One patient (5%) had complete response. Partial response was achieved in 6 (30%), disease remained stable in 10 (50%) and progressed in three (15%) patients. ECOG PS was Grade 0 in five, Grade I in 10 and Grade II in five of the 20 patients. It improved from Grade I to 0 in seven and Grade II to I in three patients. It deteriorated in three and remained unchanged in the rest seven patient;. Bone pain was present in 16 (Grade 1 in six and Grade 2 in 10) of the 20 patients. Grade I changed to Grade 0 in five and Grade II changed to Grade I in five patients. Bone pain remained unchanged in 5 (31%) and worsened in 1 (6%). Ten (62%) patients managed to cut down the dose of analgesics on daily basis. Eighteen patients had associated LUTS, which improved (Q max greater than or equal to 12 mL/sec) in 11 (61%) patients. The median duration of response was 25 weeks (range 12-72 weeks). No drug intolerance or toxicity was encountered in any patient. Conclusions: Lycopene, therapy appears to be effective and safe in the treatment of HRPC. It not only takes care of the rising PSA but also improves the ECOG performance status, bone pain and LUTS. Because of its relative innocuousness it should be tried before the use of more toxic substances. (C) 2004 Elsevier Inc. All rights reserved.