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

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00607932

Purpose

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	Intervention
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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Effects of Bassica or Indole-3-Carbinol on Prostectomy Patients With PSA Recurrence

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets Prostate Cancer Surgery

Drug Information available for: Methanol Indole-3-carbinol

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: Yes ]
Effects of intervention on prostate-specific antigen [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	March 2005
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607932

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jay H. Fowke, PhD, MPH

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000581410, VU-VICC-URO-0369, VU-VICC-041001
Study First Received:	February 1, 2008
Last Updated:	March 7, 2009
ClinicalTrials.gov Identifier:	NCT00607932 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent prostate cancer

Additional relevant MeSH terms:

Indole-3-carbinol
Anticarcinogenic Agents
Disease Attributes
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male

Protective Agents
Pharmacologic Actions
Recurrence
Neoplasms
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010