Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer
Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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:
- See Disease Characteristics
- No other concurrent Brassica vegetable consumption > 1 serving/day
- No other concurrent indole-3-carbinol supplements
- No endocrine or radiation treatment within past 4 weeks
- No other scheduled treatment during study intervention
Concurrent prescription medications during the trial allowed
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brassica Vegetables Diet Intervention
|
follow up at 2,4,6 months post baseline.
Other Names:
2, 4, 6 months post baseline
2,4,6 months post baseline
|
|
Experimental: Pill
|
follow up at 2,4,6 months post baseline.
Other Names:
2, 4, 6 months post baseline
2,4,6 months post baseline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
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
|
Not noted
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jay H. Fowke, PhD, MPH, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000581410
- VU-VICC-URO-0369
- VU-VICC-041001
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