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

April 26, 2016 updated by: Jay Fowke, Vanderbilt University

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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: questionnaire administration
Procedure: adjuvant therapy
Behavioral: behavioral dietary intervention
Dietary supplement: Brassica vegetable
Drug: indole-3-carbinol
follow up at 2,4,6 months post baseline.
Other Names:
  • I3C
Other: counseling intervention
2, 4, 6 months post baseline
Other: medical chart review
2,4,6 months post baseline
Experimental: Pill
Other: questionnaire administration
Procedure: adjuvant therapy
Drug: indole-3-carbinol
follow up at 2,4,6 months post baseline.
Other Names:
  • I3C
Other: counseling intervention
2, 4, 6 months post baseline
Other: medical chart review
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

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Jay H. Fowke, PhD, MPH, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 2, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000581410
  • VU-VICC-URO-0369
  • VU-VICC-041001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on questionnaire administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe