Clinical trial NCT00607932: Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer
Official title: Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-06
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation
timeFrame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
measure: Adverse events
timeFrame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
measure: Effects of intervention on prostate-specific antigen
timeFrame: Not noted
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jay H. Fowke, PhD, MPH
role: STUDY_CHAIR
References: