Table 1.
Completed and ongoing studies utilizing sulforaphane in patients with prostate cancer.
| Study | Design | Population | Dose and schedule | Endpoint of Interest | Key Findings |
|---|---|---|---|---|---|
| Completed Studies | |||||
| Cipolla et. al. [55] | Randomized double-blind placebo controlled multicenter (France) | Patients with PSA relapse after prostatectomy (n = 81) | 60 mg (340 μmol) “stabilized SFN” (Prostaphane®) daily for six months vs. matched placebo | Decrease in log PSA slope | Lower Log PSA slope in the SFN group compared to placebo (p = 0.01) |
| Alumkal et al [56] | Single arm Phase 2 study | Patients with PSA relapse after prostatectomy or radiation (n = 20) | 200 μmol daily for 5 months | PSA decline | 1 of 20 patients with 50% decline in PSA at 5 months |
| Traka et al. [54] | Randomized open-label trial | Patients with high-grade prostate intraepithelial neoplasia (HGPIN), (n = 22) | 400 g broccoli/week vs. 400 g peas/week for one year | Prostate tissue gene-expression changes in the broccoli arm | Significant changes in TGFβ, Insulin signaling and EGF receptor pathways |
| Ongoing Studies [www.clinicaltrials.gov, accessed February 4, 2015] | |||||
| NCT01265953 OHSU, Portland VA Medical Center | Randomized double-blind placebo controlled | Men scheduled for a prostate biopsy prior to definitive diagnosis of prostate cancer (n=100) | 30 mg (170 μmol) SFN daily for 4 weeks prior to prostate biopsy vs. placebo | HDAC inhibition (expression of acetylated H3 and H4) and DNA methylation status | |
| NCT00946309 Fred Hutchinson Cancer Research Center | Randomized double-blind placebo controlled | Men with low or intermediate- grade localized prostate cancer who have chosen prostatectomy, brachytherapy or active surveillance (n=100) | 100 μmol SFN every other day for 5 weeks vs. placebo | Gene expression of Phase II enzymes Lipid and DNA oxidation Prostate tissue dihydrotestosterone (DHT) levels |
|
| NCT01950143 (ESCAPE) Institute of Food Research, UK | Randomized double blind (three arms) | Men with low or intermediate grade localized prostate cancer on active surveillance (n= 78) | Arm 1: Standard broccoli soup Arm 2: Beneforte broccoli soup Arm 3: Beneforte extra broccoli soup (two portions of soup per week as part of normal diet for one year) |
Global gene expression | |
| NCT01948362 Evgen Pharma, UK | Randomized placebo controlled dose escalation study (Phase 1) | Male healthy volunteers ages 18 to 45 (n=29) | Escalating doses of Sulforadex® (100 mg or 300 mg stabilized sulforaphane) | Safety, Tolerance, Pharmacokinetics and Pharmacodynamics | |