Tier 2 — strong

A phase II study of sulforaphane-rich broccoli sprout extracts in men with recurrent prostate cancer

Joshi J Alumkal, Rachel Slottke, Jacob Schwartzman, Ganesh Cherala, Myrna Munar, Julie N Graff, Tomasz M Beer, Christopher W Ryan, Dennis R Koop, Angela Gibbs, Lina Gao, Jason F Flamiatos, Erin Tucker, Richard Kleinschmidt, Motomi Mori
Investigational New Drugs 2015 33(2):480-489

Bibliography

PubMed
PMID 25431127
PubMed Central
PMC4390425
DOI
10.1007/s10637-014-0189-z
Funding
Supported by Kuni Foundation Clinical Trial and Scholar Awards, a Prostate Cancer Foundation Young Investigator Award, Oregon Clinical and Translational Research Institute awards UL1TR000128/KL2TR000152, Knight Cancer Institute biostatistics support P30 CA069533, philanthropic support from Platt Electric, Bruce Burns and the Burns Family Fund, and Prostate Cancer Clinical Trials Consortium infrastructure award W81XWH-09-1-0140. The funders had no role in study design, data collection/analysis, publication decision or manuscript preparation.
Competing interests
The authors reported no conflicts of interest.

Study snapshot

DesignSingle-arm Phase II clinical study
ModelMen with recurrent prostate cancer
Sample20 participants
InterventionSulforaphane-rich extract providing 200 µmol sulforaphane daily.
DurationUp to 20 weeks
EndpointsAt least 50% PSA decline (primary); Smaller PSA declines; PSA doubling time; Safety

What the study showed, in plain terms

This early Phase II study tested a high-dose sulforaphane-rich extract in men with recurrent prostate cancer, using PSA decline as the primary efficacy endpoint.

Key findings

Only one participant achieved the prespecified 50% or greater PSA decline, so the primary endpoint was not met. Seven men had smaller PSA declines and PSA doubling time lengthened during treatment. No grade 3 adverse events were reported.

What this study can and cannot tell us

The study was small, single-arm and failed its primary endpoint. Changes in PSA doubling time are hypothesis-generating and cannot establish a treatment effect without a controlled comparison.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology