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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: behavioral dietary intervention; Other: counseling intervention; Dietary Supplement: Brassica vegetable; Other: medical chart review; Drug: indole-3-carbinol; Other: questionnaire administration; Procedure: adjuvant therapy

• Registration Number: NCT00607932
• Lead Sponsor: Vanderbilt University

Brief Summary

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

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 Timeline

• Study Start: 2005-03
• Primary Completion: 2007-01
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-02
• Study First Posted: 2008-02-06
• Study Completion: 2010-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pill	counseling intervention	-
Brassica Vegetables Diet Intervention	questionnaire administration	-
Brassica Vegetables Diet Intervention	adjuvant therapy	-
Pill	medical chart review	-
Pill	questionnaire administration	-
Brassica Vegetables Diet Intervention	behavioral dietary intervention	-
Brassica Vegetables Diet Intervention	medical chart review	-
Pill	adjuvant therapy	-
Brassica Vegetables Diet Intervention	Brassica vegetable	-
Brassica Vegetables Diet Intervention	counseling intervention	-
Brassica Vegetables Diet Intervention	indole-3-carbinol	-
Pill	indole-3-carbinol	-

Primary Outcome Measures

Name	Time	Method
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
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