NCT00607932

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	behavioral dietary intervention
DIETARY_SUPPLEMENT	Brassica vegetable
DRUG	indole-3-carbinol	follow up at 2,4,6 months post baseline.
OTHER	counseling intervention	2, 4, 6 months post baseline
OTHER	medical chart review	2,4,6 months post baseline
OTHER	questionnaire administration
PROCEDURE	adjuvant therapy

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-01-01
• Completion: 2010-11-01
• First posted: 2008-02-06
• Last updated: 2016-04-27