RATIONALE: Eating a diet high in vegetables may lower the risk of some types of cancer. Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of prostate cancer recurrence. PURPOSE: This randomized clinical trial is studying the side effects and how well Brassica vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence after surgery for prostate cancer.
OBJECTIVES: * Determine the feasibility of Brassica vegetable intake and indole-3-carbinol supplement use in patients with prostate cancer with prostate-specific antigen (PSA) recurrence after prostatectomy. * Identify adverse events in these patients. * Quantify the effects of each intervention on PSA in these patients. OUTLINE: Patients are stratified by pretreatment prostat-specific antigen (PSA) growth rate (low \[0.00-0.15\] vs medium \[0.16-0.30\] vs high \[\> 0.30\]). They are randomized to 1 of 3 treatment arms, and randomization status to arms II and III is double-blinded. * Arm I (Brassica vegetables): Patients consume Brassica vegetables at least 2 servings (½ cup/serving) daily for 6 months. Patients meet one-on-one with the study dietician, and are instructed on the potential health benefits of Brassica vegetables and purchase and preparation of the vegetables. Patients undergo telephone counseling periodically in months 1-5, to monitor their progress and identify barriers to adherence and to develop solutions to overcome these barriers. * Arm II (Placebo): Patients receive oral placebo once daily for 6 months. * Arm III (Indole-3-carbinol supplement): Patients receive oral indole-3-carbinol supplement (capsules) once daily for 6 months. Blood and urine samples (for urinary isothiocyanate levels) are collected at baseline and at 2, 4, and 6 months. Patients complete questionnaires assessing demographics, family cancer history, and health history and measuring changes in medications, lifestyle, adverse events, and health. Medical records are reviewed for prostate cancer-related information, surgical dates, dose and type of radiation, and PSA history.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
follow up at 2,4,6 months post baseline.
Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation
Time frame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
Adverse events
Time frame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
Effects of intervention on prostate-specific antigen
Time frame: Not noted
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Masking
DOUBLE
Enrollment
66
2, 4, 6 months post baseline
2,4,6 months post baseline