The Effects of Sulforaphane in Patients With Biochemical Recurrence of Prostate Cancer
I. To determine the proportion of patients who achieve a 50% decline in prostate-specific
antigen (PSA) levels within 20 weeks of sulforaphane treatment.
I. To determine the percentage change in PSA from baseline to the final measured value at
the end of study as well as the maximal PSA decline that occurs while on study for each
II. To determine the proportion of patients whose PSA has not doubled after full 20 weeks of
III. To determine the safety profile of sulforaphane. IV. To determine the pharmacokinetics
(PK) of sulforaphane and its metabolites in blood.
V. To determine the effect of sulforaphane supplementation on target pharmacodynamic (PD)
modulation in peripheral blood cells.
VI. To assess the effect of GSTM1 genotype on sulforaphane PK, PD. VII. To collect frozen
serum for future analysis of correlative biomarkers.
Patients receive sulforaphane orally (PO) once daily for 20 weeks in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 14-30 days and every 6
months for 12 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who achieve a 50% decline in Prostate-Specific Antigen (PSA) levels treatment.
To determine the proportion of patients who achieve a decline in PSA levels within 20 weeks of sulforaphane treatment as a measure of anti-tumor activity in men with recurrent prostate cancer.
Within 20 weeks of sulforaphane
Joshi J Alumkal, MD
OHSU Knight Cancer Institute
United States: Food and Drug Administration
|OHSU Knight Cancer Institute||Portland, Oregon 97239|