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

NCT ID: NCT00607932

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2010-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Brassica Vegetables Diet Intervention

Group Type: EXPERIMENTAL

behavioral dietary intervention

Intervention Type: BEHAVIORAL

Brassica vegetable

Intervention Type: DIETARY_SUPPLEMENT

indole-3-carbinol

Intervention Type: DRUG

follow up at 2,4,6 months post baseline.

counseling intervention

Intervention Type: OTHER

2, 4, 6 months post baseline

medical chart review

Intervention Type: OTHER

2,4,6 months post baseline

questionnaire administration

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

Pill

Group Type: EXPERIMENTAL

indole-3-carbinol

Intervention Type: DRUG

follow up at 2,4,6 months post baseline.

counseling intervention

Intervention Type: OTHER

2, 4, 6 months post baseline

medical chart review

Intervention Type: OTHER

2,4,6 months post baseline

questionnaire administration

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

Interventions

behavioral dietary intervention

Intervention Type: BEHAVIORAL

Brassica vegetable

Intervention Type: DIETARY_SUPPLEMENT

indole-3-carbinol

follow up at 2,4,6 months post baseline.

Intervention Type: DRUG

counseling intervention

2, 4, 6 months post baseline

Intervention Type: OTHER

medical chart review

2,4,6 months post baseline

Intervention Type: OTHER

questionnaire administration

Intervention Type: OTHER

adjuvant therapy

Intervention Type: PROCEDURE

Other Intervention Names

I3C

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Jay Fowke

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay H. Fowke, PhD, MPH

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Other Identifiers

VU-VICC-URO-0369

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-041001

Identifier Type: -

Identifier Source: secondary_id

CDR0000581410

Identifier Type: -

Identifier Source: org_study_id