Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
18 Years
N/A
Male
Prostate Cancer
Trial Information
Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation
Outcome Time Frame:
will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
Safety Issue:
No
Principal Investigator
Jay H. Fowke, PhD, MPH
Investigator Role:
Study Chair
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000581410
NCT ID:
NCT00607932
Start Date:
March 2005
Completion Date:
November 2010
Related Keywords:
- Prostate Cancer
- recurrent prostate cancer
- Prostatic Neoplasms
- Recurrence
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