This phase II trial studies how well sulforaphane works in treating patients with recurrent prostate cancer. Sulforaphane may prevent or slow the growth of certain cancers.
PRIMARY OBJECTIVES: I. To determine the proportion of patients who achieve a 50% decline in prostate-specific antigen (PSA) levels within 20 weeks of sulforaphane treatment. SECONDARY OBJECTIVES: 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 subject. II. To determine the proportion of patients whose PSA has not doubled after full 20 weeks of sulforaphane treatment. 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 Glutathione-S-Transferase Mu 1 (GSTM1) genotype on sulforaphane PK, PD. VII. To collect frozen serum for future analysis of correlative biomarkers. OUTLINE: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
Correlative studies
Correlative studies
OHSU Knight Cancer Institute
Portland, Oregon, United States
Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels
To determine the proportion of patients who achieve a decline in PSA levels while receiving sulforaphane treatment. as a measure of anti-tumor activity in men with recurrent prostate cancer.
Time frame: Less than or equal to 20 weeks of sulforaphane treatment.
Percent Change in PSA From Baseline to Final Measured Value at End of Study
To determine the percentage change in PSA from baseline to the final measured value at the end of study.
Time frame: Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.)
Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA)
Time frame: PSA measured every 28 days while on study treatment, an average of 5 months
Proportion of Patients Whose PSA Levels Have Not Doubled
Time frame: While on treatment with sulforaphane (less than or equal to 20 weeks.)
Incidence of Grade 3 or Higher Treatment Related Toxicity
Toxicities will be graded based on the NIH Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria of Adverse Events Version 4.0 (http://ctep.cancer.gov). All adverse events of any grade (for example, abnormal laboratory values, etc.) deemed clinically significant by the investigator will be recorded as a measure of the safety profile of sulforaphane
Time frame: Continually through study and 14-30 days after last drug dose.
Half-life of Sulforaphane (SFN) in Blood
Time frame: Day 1 of study treatment
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Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype
Time frame: Day 1 of study treatment
Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype
Time frame: Day 1 of study treatment