Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: behavioral dietary intervention
* Dietary Supplement: Brassica vegetable
* Drug: indole-3-carbinol
* Other: counseling intervention
* Other: medical chart review
* Other: questionnaire administration
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brassica Vegetables Diet Intervention<br> | Behavioral: behavioral dietary intervention<br> <br> Dietary Supplement: Brassica vegetable<br> <br> Drug: indole-3-carbinol<br>* follow up at 2,4,6 months post baseline.<br>* Other names: I3C;Other: counseling intervention<br>* 2, 4, 6 months post baseline<br>Other: medical chart review<br>* 2,4,6 months post baseline<br>Other: questionnaire administration<br> <br> Procedure: adjuvant therapy<br> <br> |
| Experimental: Pill<br> | Drug: indole-3-carbinol<br>* follow up at 2,4,6 months post baseline.<br>* Other names: I3C;Other: counseling intervention<br>* 2, 4, 6 months post baseline<br>Other: medical chart review<br>* 2,4,6 months post baseline<br>Other: questionnaire administration<br> <br> Procedure: adjuvant therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation |  | will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention | 
| Adverse events |  | 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 |  | Not noted | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer