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

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ClinicalTrials.gov Identifier: NCT00607932
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jay Fowke, Vanderbilt University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer 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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
Study Start Date : March 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Brassica Vegetables Diet Intervention Behavioral: behavioral dietary intervention
Dietary Supplement: Brassica vegetable
Drug: indole-3-carbinol
follow up at 2,4,6 months post baseline.
Other Name: I3C

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
Experimental: Pill Drug: indole-3-carbinol
follow up at 2,4,6 months post baseline.
Other Name: I3C

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Adverse events [ Time Frame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention ]
  3. Effects of intervention on prostate-specific antigen [ Time Frame: Not noted ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607932


Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
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Study Chair: Jay H. Fowke, PhD, MPH Vanderbilt-Ingram Cancer Center
More Information
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Responsible Party: Jay Fowke, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00607932    
Other Study ID Numbers: CDR0000581410
VU-VICC-URO-0369
VU-VICC-041001
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016
Keywords provided by Jay Fowke, Vanderbilt University:
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Disease Attributes
Pathologic Processes
Indole-3-carbinol
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents