M S Ansari1, N P Gupta. 1. Department of Urology, All India Institute of Medical Science, New Delhi, India.
Abstract
OBJECTIVE: To compare the efficacy of lycopene plus orchidectomy with orchidectomy alone in the management of advanced prostate cancer. PATIENTS AND METHODS: Fifty-four patients with histologically confirmed metastatic prostatic cancer (M1b or D2) and a performance status of 0-2 (World Health Organization) were entered into the trial between March 2000 and June 2002. The trial comprised two treatment arms, i.e. patients were randomized to orchidectomy alone or orchidectomy plus lycopene (OL), each of 27 patients. Lycopene was started on the day of orchidectomy at 2 mg twice daily. Patients were evaluated clinically before and every 3 months after the intervention, with measurements of prostate-specific antigen (PSA), a bone scan and uroflowmetry, with the clinical response assessed as the change in these variables. RESULTS: At 6 months there was a significant reduction in PSA level in both treatments, but more marked in the OL group (mean 9.1 and 26.4 ng/mL, P = 0.9). After 2 years these changes were more consistent in the OL group (mean 3.01 and 9.02 ng/mL; P < 0.001). Eleven (40%) patients in orchidectomy and 21 (78%) in the OL group had a complete PSA response (P < 0.05), with a partial response in nine (33%) and four (15%), and progression in seven (25%) and two (7%), respectively (P < 0.05). Bone scans showed that in the orchidectomy arm only four (15%) patients had a complete response, vs eight (30%) in the OL group (P < 0.02), with a partial response in 19 (70%) and 17 (63%), and progression in four (15%) and two (7%), respectively (P < 0.02). There was a significant improvement in peak flow rate in the OL group, with a mean difference of +1.17 mL/s (P < 0.04). Of the 54 patients who entered the trial, 19 (35%) died, 12 (22%) in orchidectomy and seven (13%) in OL group (P < 0.001). CONCLUSION: Adding lycopene to orchidectomy produced a more reliable and consistent decrease in serum PSA level; it not only shrinks the primary tumour but also diminishes the secondary tumours, providing better relief from bone pain and lower urinary tract symptoms, and improving survival compared with orchidectomy alone.
RCT Entities:
OBJECTIVE: To compare the efficacy of lycopene plus orchidectomy with orchidectomy alone in the management of advanced prostate cancer. PATIENTS AND METHODS: Fifty-four patients with histologically confirmed metastatic prostatic cancer (M1b or D2) and a performance status of 0-2 (World Health Organization) were entered into the trial between March 2000 and June 2002. The trial comprised two treatment arms, i.e. patients were randomized to orchidectomy alone or orchidectomy plus lycopene (OL), each of 27 patients. Lycopene was started on the day of orchidectomy at 2 mg twice daily. Patients were evaluated clinically before and every 3 months after the intervention, with measurements of prostate-specific antigen (PSA), a bone scan and uroflowmetry, with the clinical response assessed as the change in these variables. RESULTS: At 6 months there was a significant reduction in PSA level in both treatments, but more marked in the OL group (mean 9.1 and 26.4 ng/mL, P = 0.9). After 2 years these changes were more consistent in the OL group (mean 3.01 and 9.02 ng/mL; P < 0.001). Eleven (40%) patients in orchidectomy and 21 (78%) in the OL group had a complete PSA response (P < 0.05), with a partial response in nine (33%) and four (15%), and progression in seven (25%) and two (7%), respectively (P < 0.05). Bone scans showed that in the orchidectomy arm only four (15%) patients had a complete response, vs eight (30%) in the OL group (P < 0.02), with a partial response in 19 (70%) and 17 (63%), and progression in four (15%) and two (7%), respectively (P < 0.02). There was a significant improvement in peak flow rate in the OL group, with a mean difference of +1.17 mL/s (P < 0.04). Of the 54 patients who entered the trial, 19 (35%) died, 12 (22%) in orchidectomy and seven (13%) in OL group (P < 0.001). CONCLUSION: Adding lycopene to orchidectomy produced a more reliable and consistent decrease in serum PSA level; it not only shrinks the primary tumour but also diminishes the secondary tumours, providing better relief from bone pain and lower urinary tract symptoms, and improving survival compared with orchidectomy alone.
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