Table 1.

RCTs examining the effect of lycopene ONS, or the consumption of tomato-products on the PSA concentrations among men with PCa, increased PCa risk, or BPH.

First Author	Origin	Masking	Duration	Patients	Interventions	Results
Ansari [47]	IN	NR	6 mo	n = 44 men with metastatic PCa (M1b or D2)	1. Orchidectomy (n = 27) 2. Orchidectomy + lycopene ONS started on the orchidectomy day (2 × 2 mg/d) (n = 27)	At 6 mo, a reduction in PSA was noted in both arms, but at 2 yrs, it was higher in the lycopene arm. More men on lycopene had a complete PSA response.
Kucuk [49]	US	NR	3 wks until prostatectomy	n = 26 men with PCa	1. Tomato extract (30 mg of lycopene) (n = 15) 2. No ONS (n = 11)	Subjects in the tomato arm had lower PSA.
Kumar [50]	US	Double-blind	From biopsy to prostatectomy (approx. 30 d)	n = 45 men with PCa, before prostatectomy	1. Lycopene (15 mg) (n = 10) 2. Lycopene (30 mg) (n = 10) 3. Lycopene (45 mg) (n = 14) 4. No ONS (n = 11)	No difference was noted in PSA concentrations between treatment arms.
Bunker [48]	US	Open-label	4 mo	n = 77 AC men with HGPIN, atypical foci or repeated non-PCa biopsies	1. Lycopene (30 mg) + MV (n = 38) 2. MV (n = 39)	PSA declined during the 1st mo but returned to baseline concentrations by mo 4. The PSA response was identical in both groups.
Schwarz [52]	DE	Double-blind	6 mo	n = 40 men with BPH, free of PCa	1. Lycopene (15 mg) (n = 20) 2. Placebo (n = 20)	Supplementation decreased PSA concentrations in the intervention group.

AC, Afro-Caribbean; BPH, benign prostate hyperplasia; HGPIN, high-grade prostatic intraepithelial neoplasia; MV, multivitamin; NR, not reported; ONS, oral nutrient supplement; PCa, prostate cancer; PSA, prostate-specific antigen; RCTs, randomized controlled trials.