Effect of Sulforaphane in Men with Biochemical Recurrence after Radical Prostatectomy.
Level 2 - randomized trial
Individual randomized double-blind placebo-controlled trial
PubMed 25968598 · doi:10.1158/1940-6207.CAPR-14-0459
What was done
A double-blind, randomized, placebo-controlled multicenter trial assessed daily oral administration of 60 mg stabilized free sulforaphane for 6 months (M0-M6), followed by 2 months without treatment (M6-M8), in 78 men (mean age 69 ± 6 years) experiencing biochemical recurrence (increasing PSA) after radical prostatectomy. The primary endpoint was a 0.012 log (ng/mL)/month decrease in log PSA slope from baseline to month 6.
What was found
The primary endpoint was not reached. For secondary endpoints, mean changes in PSA levels from M0 to M6 were significantly lower with sulforaphane (+0.099 ± 0.341 ng/mL) compared with placebo (+0.620 ± 1.417 ng/mL; P = 0.0433). PSA doubling time was 86% longer in the sulforaphane group (28.9 months) versus the placebo group (15.5 months). A PSA increase >20% at M6 occurred in 44.4% of the sulforaphane group versus 71.8% of the placebo group (P = 0.0163). Sulforaphane effects were prominent between M3 and M6, but PSA slopes equalized between arms during the off-treatment phase (M6-M8). Compliance and tolerance were reported as very good.
Why it matters
This trial shows that oral sulforaphane can favorably alter PSA kinetics in post-prostatectomy patients with biochemical recurrence, providing proof-of-concept data for dietary phytochemically driven interventions.
Limits
The study failed to meet its prespecified primary efficacy endpoint. The sample size was relatively small (n = 78), duration was limited to 6 months of active intervention, clinical outcomes (metastasis or survival) were not evaluated, and benefits dissipated after treatment cessation.
Cited by
- supports A clinical study showed that taking 60 milligrams of sulforaphane per day slowed the progression of the biomarker prostate-specific antigen (PSA) by 86%.