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

Prostate Cancer Clinical Trial

Official title:

Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607932
• Other study ID #: CDR0000581410
• Secondary ID: VU-VICC-URO-0369
• Status: Completed
• Phase: N/A
• First received: February 1, 2008
• Last updated: April 26, 2016
• Start date: March 2005
• Est. completion date: November 2010

Study information

• Verified date: April 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2010
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• behavioral dietary intervention
Not specified

Dietary Supplement:
• Brassica vegetable
Not specified

Drug:
• indole-3-carbinol
follow up at 2,4,6 months post baseline.

Other:
• counseling intervention
2, 4, 6 months post baseline
• medical chart review
2,4,6 months post baseline
• questionnaire administration
not specified

Procedure:
• adjuvant therapy
not specified

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Adverse events		will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention	Yes
Primary	Effects of intervention on prostate-specific antigen		Not noted	No