Prostate Cancer
Conditions
Keywords
recurrent prostate cancer
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.
Interventions
BEHAVIORALbehavioral dietary intervention
DIETARY_SUPPLEMENTBrassica vegetable
follow up at 2,4,6 months post baseline.
OTHERcounseling intervention
2, 4, 6 months post baseline
OTHERmedical chart review
2,4,6 months post baseline
OTHERquestionnaire administration
PROCEDUREadjuvant therapy
Sponsors
National Cancer Institute (NCI)
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation | will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention |
| Adverse events | 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 | Not noted |
Outcome results
None listed