A group of investigators, interested in the influence of lycopene on both the clinical and laboratory progression of advanced prostate cancer in men with hormone refractory prostate cancer, ran a small prospective Phase II pilot study.

The researchers gave lycopene supplementation (15 mg) daily for 6 months to their trial subjects. They performed follow up laboratory tests and clinical examinations on a monthly schedule. The investigators evaluated the changes of analgesic (pain medication) use and the quality of life (European Organization for Research and Treatment of Cancer QLQ-C30) as measurements. The study end point was a significant change in serum prostate specific antigen (PSA) and clinical progression of the disease at the end of the 6-month observation period.

A total of 18 survivors 64 to 85 years old (median age 73) were enrolled in the study during a 20-month period. Data from 17 of the 18 men were able to be analyzed.

Five of the 17 patients (29%) withdrew from the study prematurely, including 4 of 5 because of PSA progression and/or tumor associated complications, and 1 due to an allergic reaction to lycopene. The median PSA doubled in 6 months from 42.7 ng/ml (range 13.8 to 521.6) in 17 patients to 96.4 ng/ml (range 13.5 to 1,240) in 12. Stable PSA was observed in 5 of 17 patients (29%).

None of the survivors had a greater than 50% decrease in PSA. Survivors experienced a slight deterioration in mean health status at the end of the study compared to the outset. However, two-thirds of the patients experienced an improved or unchanged situation regardless of the clinical and biochemical course.

The researchers simple conclusion was that there were no clinically relevant benefits of lycopene consumption demonstrated for survivors with hormone refractory disease. Once again, we have been let down and frustrated by our use of supplements to control this disease.

However, we cannot automatically assume that lycopene consumed with our food (tomato sauce, etc.) will not help control the cancer, but we do need to be skeptical about its benefits. Often, supplements do not have the same effect as when the substance is consumed as a part of our nutrition.

From the Departments of Urology and Paediatric Urology and Philipp-Klee-Institute for Clinical Pharmacology (PT), Witten/Herdecke University, Witten and Helios-Hospital of Wuppertal, Wuppertal, Germany.

J Urol. 2009 Jan 14. Epub ahead of print.

PubMed Abstract