Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
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Diagnosis of prostate cancer with PSA recurrence after prostatectomy
- PSA recurrence is defined as two consecutively rising PSA tests ≥ 8 weeks since the post-surgical nadir, with a minimal interval of 2 weeks between tests and at least 1 PSA test > 0.4 ng/mL
Exclusion criteria
- Life expectancy ≥ 9 months
- No predictors of poor adherence (e.g., erratic life-style, mental incompetence)
PRIOR CONCURRENT THERAPY:
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See Disease Characteristics
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No other concurrent Brassica vegetable consumption > 1 serving/day
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No other concurrent indole-3-carbinol supplements
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No endocrine or radiation treatment within past 4 weeks
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No other scheduled treatment during study intervention
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Concurrent prescription medications during the trial allowed
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At least 2 weeks since prior and no concurrent vitamin or herbal supplement use
- Patients refusing to stop non-study supplements will be asked to maintain constant use
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Trial design
Primary purpose
Allocation
Interventional model
Masking
66 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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